IVF (in vitro fertilization)

Main article: Pregnancy and childbirth

IVF as a method to treat infertility

Main article: Infertility

For 2019, the main methods of treating infertility are methods of assisted reproductive technologies. These include:

• intrauterine artificial insemination procedures with husband or donor semen (IMI) and
• various modifications of in vitro fertilization (IVF/ICSI).

There are forms of infertility that can only be overcome by IVF (serious hormonal disorders, lack of fallopian tubes, with male infertility and with infertility of unclear origin) - IVF is the only opportunity to conceive.

One of the more popular myths around IVF is that the main cause of infertility is the female factor, it really isn't. Statistics suggest that in 1/3 of cases the cause is female infertility factor, in 1/3 of cases the male infertility factor, and in 1/3 of cases infertility of unclear genesis. Most often, the root causes of infertility are metabolic disorders, oxidative stress, hormonal imbalance, obesity, psychological imbalance in the pair. To prevent this, doctors are actively preparing patients in advance both for the IVF program and for further pregnancy, trying to minimize the risks of complications, said in May 2019 Ekaterina Perevoznikova, obstetrician-gynecologist, reproductologist, JSC "Medicine," member of the Russian Association of Human Reproduction.

IVF fertility dynamics

The first successful case of IVF was recorded on July 25, 1978 in the UK. In Russia, the first child "from a test tube" was born in 1986.

If in 1990 about 20,000 children were born in the world through IVF, in 2012 the number was already more than 5 million, and in 2018 - more than 8 million. Among the leading countries in the field of in vitro fertilization are Spain, Russia, Germany, France and the United Kingdom.

IVF effectiveness depends on age

Number of attempts for each patient individually. The effectiveness of IVF depends on the age of the patients, the duration of infertility in the pair, the number of previously conducted programs, the patient's ovarian reserve and the quality of the partner's sperm, the implantation potential of the endometrium, the presence of independent pregnancies in the pair ended with childbirth and the absence of extragenital pathology. Of course, the older the patient, the lower the efficacy. So the frequency of pregnancy per 1 IVF program in patients under 29 years old is 83%, in patients aged 30-34 years - 61%, 35-39 years - 34%, in patients over 40 years old - 27.6%, and with the use of donor oocytes already 71%.

Vitamin D deficiency affects reproductive function as a whole: achieving vitamin D standard targets significantly increases the efficiency of obtaining high quality cells and a successful pregnancy outcome, which makes it possible to declare a high probability of giving birth to a healthy baby without risks for mom.

Using Hatching, PIXI, IMSI, or ICSI

Hatching is an auxiliary technique that allows you to increase the likelihood of embryo implantation. There are indications for hatching:

• idiopathic infertility,
• the patient's older reproductive age (over 38 years),
• the thickened membrane of the embryo,
• IVF failures in the past.

ICSI, PIXI, IMSI, is the selection of the best sperm for fertilization. It is most often used for the male infertility factor.

IVF Program Price

As of June 2019, the price of the IVF program without drugs starts from 140,000 to 180,000 rubles.

MHI IVF

For June 2020, Russians can undergo IVF for free under the Campus Management compulsory medical insurance policy.

2023

Reduction of government spending on IVF under compulsory medical insurance

In 2024, government spending on the in vitro fertilization (IVF) procedure in federal medical centers will be reduced by 28.7%. The Ministry of Health of the Russian Federation told about this in October 2023.

According to the ministry, the average cost standards per unit of medical care in IVF will amount to 108 426.4 rubles in 2024, 115 907.8 rubles in 2025 and 123 673.6 rubles in 2026.

The Ministry of Health noted that such a decision was caused by the fact that the actual average cost of IVF medical services in 2023 was lower than the established one. The costs of this procedure were reduced due to the more efficient organization of procurement of consumables and import substitution.

At the same time, within the framework of the Demography national project, the planned expenses included an increase in the average standards for the volume of medical care in IVF, which will increase the availability of assisted reproductive technologies for citizens, the press service of the Ministry of Health told Parlamentskaya Gazeta.

At the same time, the volume standard, that is, the average number of cases of IVF for a year, should increase. Compared to 2023, the total figure increased by 2.6%. The department explained that it is necessary to increase the volume of procedures due to the target indicators of the national project "Demography," which prescribes to conduct at least 78 thousand IVF cycles in 2024 for families suffering from infertility at the expense of compulsory medical insurance.

Yuri Zhulev, co-chairman of the All-Russian Union of Patients, noted that when drawing up a draft program of state guarantees for the provision of free medical care for 2024-2026, specialists analyze many parameters, including the cost of consumables, the demand for such a procedure, prices in different clinics. However, he added that his organization is concerned about reducing funding in any area of ​ ​ health care, including^[1]

The Ministry of Health of the Russian Federation approved new technologies for obstetrics and IVF, on which 1.1 billion rubles will be spent

On June 16, 2023, the Ministry of Health of the Russian Federation published protocols for clinical approvals, according to which permission was given to provide medical care until 2025. In particular, we are talking about the use of new technologies in the field of obstetrics and in vitro fertilization (IVF).

It is noted that eight protocols are presented in the field of obstetrics-gynecology: all of them were developed by the National Medical Research Center of Obstetrics, Gynecology and Perinatology named after V.I. Kulakova. The documents cover primarily such areas as surgery and therapy to assist patients with gynecological diseases, as well as services under the IVF program.

Ministry of Health of the Russian Federation approved new technologies for obstetrics and IVF

In total, as Medvestnik clarifies, approximately 1.1 billion rubles will be spent on the implementation of new methods in obstetrics and IVF during the first half of 2023. For comparison: in 2022, about 743 million rubles were allocated for the relevant areas. More than 2 thousand married couples will receive medical care using new technologies. Of these, up to 715 pairs are planned according to the protocol under the IVF program, the purpose of which is to introduce a "method of activating the oocyte in patients with no fertilization in previous programs." Activation can be carried out by physical or chemical stimulation: this is said to increase the chances of fertilization after an intracytoplasmic sperm injection. The costs of this method are almost 348 million rubles. The goals are to "increase the frequency of fertilization and select embryos to exclude pathologies."

In the direction of assistance to patients with gynecological diseases, the use of a robot-assisted hysterectomy is distinguished. In this case, surgical instruments are held by special manipulators, and control is carried out using joysticks on the console.^[2]

2022

The number of IVF cycles for compulsory medical insurance over 5 years increased by 47.3%

In 2022, the number of IVF cycles carried out Russia at compulsory health insurance (compulsory medical insurance) the expense of the basic program increased by 47.3% compared to 2017. The deputy Governments of the Russian Federation Tatyana Golikova chairman cited these figures at a meeting of the Council for Strategic Development and National Projects with the participation of the president on of the Russian Federation Vladimir Putin December 21, 2023.

According to Golikova, for the entire 2022 and incomplete 2023 in the Russian Federation, about 19 thousand children were born, conceived using the IVF procedure.

For the entire 2022 and incomplete 2023 in the Russian Federation, about 19 thousand children were born, conceived using the IVF procedure

As the Deputy Prime Minister noted, in all regions, women who are in a situation of reproductive choice are provided with legal, psychological and medical and social assistance by more than 600 units and offices for pregnant women.

To obtain a quota for IVF under compulsory medical insurance, you need to be examined at the antenatal clinic. If there are indications, the obstetrician-gynecologist will give a referral to the nearest perinatal center for a consultation with a reproductive specialist. After receiving the conclusion, the reproductologist will put the patient on the waiting list for IVF right at the appointment.

In September 2023, the Ministry of Health of the Russian Federation said that since the beginning of the implementation of the Demography national project, more than 273 thousand IVF procedures for compulsory medical insurance have already been carried out.

In vitro fertilization can be obtained if the couple is diagnosed with infertility that cannot be treated, or diseases that prevent pregnancy are found. The referral for the free procedure is given in the antenatal clinic, and the medical center where the IVF cycle will be carried out, the couple can choose on their own. By the end of 2024, it is planned to conduct 450 thousand IVF cycles according to the national project "Demography," according to the Ministry of Health of the Russian Federation in September 2023.^[3]

MHIF: The share of successful IVF in Russia - 19.4%

In 2022, 92,826 procedures for in vitro fertilization (IVF) were carried out according to compulsory medical insurance, of which 18,088 cases ended in childbirth. Such data at the end of November 2023 were cited by Olga Tsareva, deputy head of the Federal Compulsory Medical Insurance Fund (MHIF).

According to her presentation, the effectiveness of IVF in Russia at the end of 2022 amounted to 19.49%. The lowest results were shown by the following Planned Parenthood clinics:

• ECO Center LLC (Kabardino-Balkarian Republic), where in 2022, out of 187 cycles of assisted reproductive technologies (ART), only five cases ended in childbirth;
• Skanfert LLC (Petersburg), 158 cycles and 6 successful results;
• CIER Embrylife (Petersburg), 206 cycles and 10 hospitalizations for delivery.

In 2022, 18,088 successful IVF procedures were carried out under compulsory medical insurance

The statistics of the MHIF include only IVF in the system of compulsory medical insurance, but many procedures take place in private medicine, and taking into account it, the final efficiency in Russia may be higher. As the "Medical Bulletin" writes about the reference to the data of unnamed experts, the effectiveness of IVF in Russia is about 35% after the first attempt and 40% after the second. The result is influenced by the length of service and the cause of infertility, as well as the age of the woman (the effectiveness of IVF decreases as the woman's age increases), the newspaper notes.

In 2024, the MHIF will introduce new criteria for the quality of medical care in the IVF procedure to assess clinics receiving funding from the compulsory medical insurance, Olga Tsareva said at the end of November 2023. It is planned to monitor the proportion of patients examined before RT in accordance with the clinical guidelines "Female infertility"; the number of cycles performed by the medical organization during the year; The proportion of patients who completed the RT cycle with childbirth.^[4]

The Ministry of Health announced the advance of the indicators of the national project in the number of free IVF procedures

In November 2022, the Ministry of Health of the Russian Federation reported ahead of the indicators of the national project in the number of free in vitro fertilization (IVF) procedures.

For 9 months of 2022, 62.5 thousand IVF procedures were carried out, over 89.5 thousand are planned for 2023, which is 18% more than in 2022. The Ministry of Health calls this an additional contribution of the health care system to increasing birth rates.

The Ministry of Health announced the advance of the indicators of the national project in the number of free IVF procedures

Ministry of Health Russia continues to develop the use of assisted reproductive technologies. Thus, the availability of the in vitro fertilization (IVF) procedure for infertility patients is growing, "Aleksey Kuznetsov, Assistant Minister of Health of the Russian Federation, told reporters.

The development of the use of assisted reproductive technologies is provided for by the national project "Demography." The project passport for 2023 included at least 78 thousand IVF cycles. In total, during the duration of the program (2019-2024), it was planned to perform at least 450 thousand cycles at the expense of the Campus Management compulsory medical insurance base program.

MHI IVF includes stimulation of superovulation with the use of drugs, puncture of ovarian follicles with transvaginal access under the control of ultrasound to obtain eggs, artificial fertilization of the obtained cells, cultivation of embryos, transfer of embryos.

If desired, a woman can also use the embryo cryopreservation service for the amount provided for by the federal state guarantee program, but it does not include storage.

The IVF procedure is carried out according to the compulsory medical insurance policy, subject to several conditions:

• a woman has Russian citizenship and a valid compulsory medical insurance policy;
• the couple has no children together, while registration of marriage between a man and a woman is not required;
• absence of contraindications to IVF and pregnancy;
• normal physical and mental health;
• the factor of infertility (male or female) has been established^[5]

2019

Accounts Chamber: 79.6 thousand IVF procedures for 9.9 billion rubles were carried out due to compulsory medical insurance

In 2019, 79,566 thousand IVF cycles were performed in Russia in the amount of 9.9 billion rubles when using Campus Management compulsory medical insurance funds, which is 13.7% more than planned when drawing up the national project "Demography." This is stated in the report of the Accounts Chamber (JV).

In 18 regions, with unfulfilled volumes of medical care, the funds were spent in full. In 11 subjects, the opposite picture is that the plan for the volume of medical care is overfulfilled, and the funds are not fully used.

This indicates that the approval of the volumes of IVF and the corresponding financial support of these measures in territorial programs is carried out without taking into account the real needs and peculiarities of the regions, "said Galina Izotova, Deputy Chairman of the Accounts Chamber, at the board following the audit.

In 2019, 79.6 thousand IVF procedures worth 9.9 billion rubles were carried out due to compulsory medical insurance

The review identified other regulatory gaps as well. Thus, the program of state guarantees for the provision of free medical care to citizens does not oblige the regions to set deadlines for waiting for IVF in their territorial programs. As a result, in different regions, they can vary from one month to one and a half years. The mechanism for distributing the amount of assistance between medical organizations is not sufficiently settled.

The authors of the report also note the low availability of reproductive technologies for the population. For example, some IVF-related services (preimplantation genetic testing, drug support in the post-transfer period, and others) are not paid for by compulsory medical insurance.

The control body proposed to the Ministry of Health and the MHIF to revise the principle of calculating the average standard of financial costs per IVF case and the procedure for applying methods of payment for medical care, as well as to develop a more transparent mechanism for distributing the amount of assistance, after it revealed the problems of regulatory regulation of the organization and the procedure for medical care at the expense of compulsory medical insurance between medical organizations.^[6]

The number of IVF for compulsory medical insurance in Russia for the year increased by 15%

At the end of 2019, about 80 thousand cycles of in vitro fertilization (IVF) procedures were performed in Russia due to the basic compulsory health insurance (compulsory medical insurance) program. This is 15% more than a year ago, and the regions are making an increasingly large contribution to these statistics. Such data in early June 2020 were cited by Russian Minister of Health Mikhail Murashko at the congress "New technologies in the diagnosis and treatment of gynecological diseases."

Today, we have practically minimized waiting times for a patient who plans to receive this medical service and find the happiness of motherhood, he added.

In 2019, 80 thousand cycles of IVF according to compulsory medical insurance were carried out

Mikhail Murashko said that by the beginning of June 2020, the ministry and relevant specialists are "discussing" what are the "weak points" in the use of IVF technology, how to increase its safety so as not to reduce the volume of the procedure and its availability.

Within the framework of  the national project "Demography," which is aimed at reducing population loss, from 2019 to 2024 it is envisaged to conduct at least 450 thousand cycles of in vitro fertilization. According to Murashko, in recent years in Russia there has been a constant decrease in maternal and infant mortality.

The Ministry of Health notes that free IVF is carried out according to indications in cases where other methods of treating infertility are not effective. There is a certain scheme for the selection of patients for IVF. If a woman has no contraindications, if she is shown fertility treatment by the method of assisted reproductive technologies, the woman is examined and receives a referral to the clinic, which she chooses, the department said.^[7]

IVF at the expense of compulsory medical insurance: who and how can get a quota

Fertility treatment using in vitro fertilization has been included in the compulsory health insurance (compulsory medical insurance) program since 2016 and is carried out throughout Russia. The procedure for using assisted reproductive technologies (hereinafter referred to as ART), contraindications and restrictions for their use were approved by Order of the Ministry of Health of Russia dated 30.08.2012 No. 107n, according to which the indications for the IVF program are diseases in which pregnancy is impossible without this procedure, as well as diagnosed infertility that cannot be treated for 9-12 months.

Indications for IVF are a number of diseases and conditions in both men and women, including:

• anovulation;
• infertility associated with inflammatory diseases or tubal obstruction;
• severe disorders on the part of the male reproductive system;
• hormonal pathology, e.g. increased estrogen production;
• ovarian dysfunction;
• polycystic ovary syndrome;
• endometriosis;
• the cervical factor of infertility.

In which medical organizations can you undergo IVF on compulsory medical insurance?

In vitro fertilization under the state program is carried out in both state and private paid clinics participating in the implementation of territorial compulsory medical insurance programs. Medical organizations established as Centers for Assisted Reproductive Technologies, or medical and other organizations with a laboratory (department) of assisted reproductive technologies in the structure, are entitled to provide medical assistance using the methods of assisted reproductive technologies, if there is a license to carry out medical activities in obstetrics and gynecology (use of assisted reproductive technologies).

Among the restrictions on the application of the basic IVF program, it should be noted:

• hereditary diseases (hemophilia, Duchenne muscular dystrophy, X-chromosome-related ichthyosis, Charcot-Marie neural amyotrophy, etc.);
• severe somatic diseases;
• study-confirmed reduction in ovarian reserve;
• conditions in which treatment using the basic IVF program is ineffective and the use of donor and/or cryopreserved germ cells and embryos, as well as surrogacy, is indicated.

Procedure for obtaining an IVF quota

If the treatment of infertility was considered ineffective and the pregnancy did not occur within 9-12 months, the attending physician, in whom the woman was examined and treated, refers the patient to the IVF procedure. An extract from the medical documentation, certified by the signature of the attending physician, the signature of the head of the guiding medical organization and the seal of the medical organization, containing the diagnosis of the disease, information about the patient's health, the results of laboratory, instrumental and other types of studies confirming the established diagnosis, indications for the need for IVF procedure, the patient's absence of contraindications and restrictions should be attached to the referral for IVF.

The package of documents shall be sent to the Commission established under the constituent entity of the Russian Federation for selection of patients for IVF procedure (hereinafter referred to as the Commission). The Commission, having considered the documents, with a positive decision, which is drawn up by the relevant protocol, issues a referral (coupon) in the established form, for the IVF procedure. The deadline for making a decision is 10 working days.

A woman is included in a waiting list, which is formed in electronic form with an indication of the patient's queue and cipher (without personal data), which makes it possible to track all movements in turn, through the official website on the Internet of the authority of the constituent entity of the Russian Federation in the field of health care.

From the list of medical organizations submitted by the commission or CMO, the patient is independently determined with a clinic that participates in the state guarantee program. Representatives of the commission can only make their recommendations. An insurance medical organization in which the woman is insured can also provide such a list. The woman is independently determined with the clinic from the list presented, the chosen medical organization has no right to refuse her hospitalization without objective reasons. When choosing an MO, it is not necessary to rely on territorial proximity.

In the absence of pregnancy, patients can be re-included in the waiting list, provided that the order is followed and a newly assembled package of necessary documents is provided to the Commission. Within one calendar year, it is possible to carry out no more than 2 IVF attempts.

Possible violations of patients' rights

• An examination to establish the causes of infertility for both women and men should be carried out within 3-6 months. Failure to comply with and delay in these deadlines is a criterion for the unsatisfactory quality of medical care for infertility. If the patient is faced with non-compliance with the deadlines on the part of a medical organization, he should contact his insurance medical organization by phone indicated on the compulsory medical insurance policy. By law, health insurance organizations have a duty to monitor the quality of care and protect the interests and rights of patients.

• To obtain a quota, you need to collect a package of documents required by the medical commission. In a situation where, having applied to a medical organization providing compulsory medical insurance services, the patient is refused IVF due to the lack of a quota, he should also contact his insurance medical organization to clarify the details.

• Most of the examinations necessary for the IVF procedure are included in the compulsory medical insurance program, that is, the examination can be carried out free of charge. If the clinic asks to pay for any analysis or study, the patient can find out whether this is legitimate or not by calling his insurance medical organization, whose representative will clarify the information and, if necessary, contact the administration of the medical organization to resolve the situation.

• Also, in your insurance medical organization, you can clarify the regional features and conditions for performing the IVF procedure - what studies are included in the compulsory medical insurance in this territory, what documents need to be collected in a particular region, whether it is possible to get a referral for IVF over a certain age.

Technology development

2024

Ultrasound technology developed that increases sperm motility by 266% for IVF

On February 16, 2024, Australian scientists from Monash University announced the development of ultrasonic technology that allows several times to increase the mobility of flaccid sperm. This is said to open new avenues for fertility treatment in a non-invasive way. Read more here.

Test designed to determine quality of embryos for biopsy-free IVF

On January 10, 2024, US researchers at the University of California, San Diego School of Medicine reported the development of a non-invasive method that could be used to better predict the quality of lab-grown embryos for the in vitro fertilization (IVF) procedure. The new approach is expected to help raise the likelihood of a successful pregnancy.

It is noted that IVF technology has given hope to many people who cannot conceive a child in the traditional way. However, this complex multi-step process only provides a 20-40% chance of success in women younger than 40. One reason is that it is very difficult for doctors to determine which artificial embryos are most suitable for insemination. The proposed method solves the problem.

Non-invasive method developed for embryo quality analysis for IVF

The technology relies on the detection of small particles of genetic material called exRNAs that remain in the liquid medium used to grow the embryos. Instead of relying on visual characteristics or biopsy, the approach developed is more like a blood test. Although DNA contains all the instructions the cells need to develop and function, they also need RNA. The main part of RNA is inside the cells, but some molecules - exRNA - are released into the environment while the cell performs various functions.

By analyzing exRNA in the embryo culture medium at five different stages of development, the researchers identified about 4,000 different exRNA molecules at each stage. They correspond to many different genes that are expressed in embryos at different stages of development. Thus, it is possible to analyze the sample outside the cell and get an idea of ​ ​ what is happening inside it. The researchers used this data to train an AI model to predict embryo morphology. This model is able to replicate morphological measurements used in current embryo tests, making it a promising predictor of quality.^[8]

2023

Russia has learned to detect cystic fibrosis during IVF

Scientists from the Tomsk National Research Medical Center (NMIC) of the Russian Academy of Sciences have developed technology that will help identify such a severe hereditary disease as cystic fibrosis at the IVF stage. Read more here.

R-Pharm brings KOEK microfluidic sperm sorting chips to market

The R-Pharm Group of Companies received a marketing authorization (RZN 2023/21148 from 22.09.2023) for FERTILE, FERTILE PLUS and FERTILE ULTIMATE microfluidic chips. These are sterile products for single use, the principle of which is to separate sperm by their motility in the microenvironment. The project is being implemented under an agreement with the Turkish biotechnology company Koek Biotechnology. R-Pharm announced this on October 30, 2023. Read more here.

Russia has developed a new method for selecting viable sperm for IVF. It is based on cancer technology

In early July 2023, specialists from Sechenov University announced the creation of a new method for selecting the highest quality and viable sperm. This is time-resolved fluorescence microscopy (FLIM). Read more here.

Copies of human embryos from stem cells created for the first time in the world

In mid-July 2023, scientists at the University of Cambridge created synthetic human embryos using stem cells, a revolutionary move to dispense with the use of eggs or sperm. Read more here.

In Russia, began the production of drugs for IVF

In February 2023, the Ural Medsintez Plant"" announced its readiness to completely replace imported drugs for IVF c. As Russia part of these plans, the company has already begun production of one of these drugs - recombinant follicle-stimulating hormone (FSH) for human treatment infertility "Primapur." More here.

3D printing began to be used for IVF

In late January 2023, the researchers created a dynamic cell culture that could significantly improve the in vitro fertilization process using a unique polymer material and 3D printing process. Read more here.

Prediction model developed for optimal number of IVF embryos for specific pairs

On January 3, 2023, the results of a study to develop a model for predicting the optimal number of immature eggs or oocytes needed to attempt fertilization through assisted reproductive technologies such as in vitro fertilization (IVF) were published.

IVF usually involves four main stages: induction of ovulation, extraction of the egg, its fertilization and implantation of the embryo. During this process, embryologists must choose which embryos to implant, cryopreserve, or dispose of. Embryos that are considered suitable for IVF are cryopreserved in case the initial transfer for one reason or another cannot be carried out within a certain period of time. Other embryos that are considered unsuitable or otherwise unused must be destroyed. But this practice causes ethical controversy and creates additional difficulties for IVF clinics.

Model for prediction of optimal number of embryos for IVF developed

A new technique for predicting the optimal number of embryos for IVF was proposed by American researchers from Amherst College (Massachusetts). The developed model allows you to determine how many oocytes should be exposed to sperm, taking into account the preservation of the chances of live birth and minimizing the number of unused embryos.

To develop the technology, the researchers used actual data from member institutions of the Society for Assisted Reproductive Technologies (SART) Clinical Results Reporting System from 2014 to 2019. Information was analyzed on 410,719 oocyte recoveries and 460,577 embryo transfer cycles in 311,237 patients aged 18 to 45 years. The proposed algorithm takes into account the patient's age, the level of anti-Muller hormone, the diagnosis of reduced ovarian reserve, the number of oocytes extracted and other parameters. The study found that the new prediction model helps reduce the number of unused embryos, which could help address current ethical challenges.^[9]

2022

The market for genetic testing of embryos in Russia was estimated at $13 million

The volume of the Russian market for genetic testing of embryos for chromosomal abnormalities (PGT) in 2022 exceeded $13 million. Such data in June 2023 led to Genetico.

According to experts, 8.5% of all IVF cycles were carried out in Russia with PGT over the year. The penetration rate of services into healthcare in Russia is lower than in the USA (25%) and China (10.16%), and has growth potential. The prevalence of PGT in Russia increases by an average of + 1% annually, the report said.

The volume of the Russian PGT services market exceeded $13 million

PGD (the terms PGS (preimplantation genetic screening) and PGT (preimplantation genetic testing) are also used to study the genetic code of an embryo obtained by in vitro fertilization (IVF). For each embryo, the geneticist gives an opinion on the basis of which the reproductologist, together with the patient, will be able to decide on the transfer of a specific embryo to the female uterine cavity. According to the Russian Association for Human Reproduction (RARCHA), the proportion of IVF cycles using GGT is increasing - by the end of 2020 (this is the latest data), genetic testing was carried out in at least 12.6 thousand cycles of ART, in half of the cases (6 thousand) embryos were transferred to a woman, in 2 thousand cases childbirth occurred.

According to Genetico medical director Elizaveta Musatova, embryotest and PGT in general are actively used by reproductive doctors. Both doctors and patients see the effectiveness of this technology. With PGT instead of 3-4 cycles of IVF, the patient receives pregnancy on cycle 1-2, she noted.

According to the Russian Association of Human Reproduction in Russia, which are given in the Genetico study in June 2023, over the past 7-10 years there has been an increase in both the total number of IVF cycles and IVF cycles with PGT.^[10]

Russia has developed a technique that will help you get pregnant without IVF

The company "System-BioTech" (included in) AFK Sistema has developed that PreMama genetic test is able to identify non-obvious causes of non-occurrence pregnancies and give recommendations for correcting genetically the embedded imbalance of metabolites in the body. In turn, this can contribute to the normalization of reproductive function and help get pregnant before using assisted IVF technology. This was Zdrav.Expert reported by representatives of Sistema-BioTech on December 8, 2022. More. here

Conception from three parents turned out to be safe for the fetus

On September 6, 2022, the first comprehensive study of the technique for mixing the genetic material of three people on embryos at an early stage of development was published. Scientists reported that the technique does not affect their development.

The technique of using genetic materials of three people in the creation of embryos was developed in order to prevent their transmission to children by mothers with defects in mitochondria - organelles that supply cells with energy. The mitochondria contains its own DNA and the baby inherits the mitochondria entirely from the mother.

Conception from three parents turned out to be safe for the fetus

Mitochondrial replacement is an ambiguous area, "said study co-author Wei Shang, an obstetrician-gynecologist at China's PLA General Hospital in Beijing. "With our research, we expect to pave the way for the development of this technique.

In the study, the scientists compared dozens of human embryos undergoing fusiform transfer and a control group of embryos. Both embryo groups were allowed to develop within one week of fertilization. The scientists determined that the five-day blastocyst cells in each group had virtually identical levels of gene expression and transcription, suggesting that spindle transfer had no effect on early embryonic development.

This is the first work to make a comprehensive comparison of human embryos created by spindle transfer, says Dietrich Egley, a stem cell biologist at Columbia University in New York. He added that the study is "unique and outstanding" because of its high quality and the large amount of data it contains.

It can really help to advance in this area, "he said.[11]

2021

Role of artificial intelligence in IVF efficiency

By early December 2021, a group of startups had formed in the medical technology market, whose artificial intelligence technologies help improve IVF procedures. This topic is devoted to an article on the Bustle portal.

In the in vitro fertilization cycle, a qualified embryologist examines sperm and eggs to identify viable candidates for successful fertilization. Using a thin needle, microscope and hard arm, they connect healthy sperm and eggs to create embryos, which are then transferred to the uterus. As long as people do this work, there will never be 0% errors, and the computer will not get tired of doing the same work every day. Even the slightest mistake can lead to the egg, which is a very deficient cell, being spoiled.

The impact of artificial intelligence (AI) on home testing kits will not so much affect IVF success rates as speed up the process for people wanting to learn about their fertility. While Mojo home testing kits do not necessarily correlate with a higher likelihood of conceiving a test pair, the test itself contributes to a higher IVF success rate for everyone. Not only will it help improve IVF performance, it will also provide healthy families, more hardy sperm can also reduce the risk of miscarriage.

Artificial intelligence improves IVF

Other fertility start-ups are increasingly relying on AI accuracy. For example, Mira helps women plan their conception more accurately by using home laboratory hormone control to determine ovulation. Alife, is a program that uses data from past successful IVF trials to find winning models in viable sperm and eggs.

In the Life Whisperer cloud app, AI helps embryologists assess the quality of embryos and the likelihood that one of them will lead to the birth of a healthy, full-fledged child. The technology helps embryologists decide which embryo to transfer to a patient to choose the best and avoid unnecessary IVF procedures. The program is simple: Drag images of embryos from standard lab microscopes into a web application for AI technology to analyze them and evaluate them in seconds, a result that raises the success rate for viable samples to more than 70%.

While it will be years before clinics do enough research and process data to broadly introduce AI technology into fertility care, experts hope AI programs will complement human work and significantly reduce errors. High-tech data-based tools and robot accuracy will be an invaluable help for doctors and will increase the percentage of successful operations. AI has a great future in IVF and a high probability that it will complement the standard of treatment thanks to its objectivity and predictive power.^[12]

Entry of microfluidic chips for sperm selection in Fertile IVF procedures into the Russian market

On March 19, 2021, the R-Pharm group announced the conclusion with the Turkish biotechnology company Koek Biotechnology of an agreement on the supply of Fertile microfluidic chips for in vitro fertilization (IVF) to the Russian market. The deal involves the registration and distribution of Fertile, Fertile Plus and Fertile Ultimate devices. Read more here.

2020: Announcement of a device for selecting high-quality sperm for IVF

In mid-December 2020, researchers from Monash University Australia in developed a microfluidic device to isolate high-quality sperm from samples for IVF. The new technology uses standing acoustic waves to separate sperm in clinically relevant amounts, and it is faster, less time-consuming and not as dangerous to sperm as current centrifugation and washing procedures. According to the developers, their system has already begun to be used in treatment clinics. infertility More. here

2019: Clinics begin to define disease tendency and embryo's mental capacity before IVF

In November 2019, Genomic Prediction announced the creation of a test that determines the genetic predisposition and mental abilities of embryos before the in vitro fertilization (IVF) procedure. The new solution is called LifeView. Read more here.

2018: Artificial intelligence unveiled to boost IVF success by 20%

At the end of December 2018, experts from the University of Cornwall in the USA and Imperial College in London demonstrated the results of their study, according to which the effectiveness of IVF can be increased by 10-20% if artificial intelligence (AI) is used to assess the quality of embryos.

Half of all miscarriages are caused by an abnormal number of chromosomes in the embryo. Developing algorithms to assess embryos before being transferred to the uterus is considered key to IVF success. A new study shows that AI trained in images of hundreds of embryos can predict the success of hatching with an accuracy of 85%. In the tests, the computer analyzed images of 328 embryos implanted in expectant mothers. When asked which of the embryos were able to survive, he correctly determined the probability in 280 cases. AI continues to analyze the resulting data, adapting its algorithm to make it even more accurate.

Researchers from the University of Cornwall in the US and Imperial College in London demonstrated the results of their research, according to which the effectiveness of IVF can be increased by 20% if AI is used to assess the quality of embryos

The AI system is based on time-lapse photography of growing embryos, which is already used in many fertility clinics. Every 10 minutes, the embryo is photographed and the resulting image is transmitted to embryologists who assess its condition. Such a non-invasive assessment reduces the risk of embryo damage.

The researchers note that the birth of a healthy child in IVF depends not only on the viability of the embryo, but this factor is responsible for 80-90% of success. In research clinics, the probability of carrying a healthy child when using IVF and time-lapse shooting in a woman under 35 without any health problems is 50%. When using AI, this figure can increase to 60-70%.

Researchers believe the technology could become available within the next five years, revolutionizing fertility treatment. At the same time, hospitals and clinics will not have to buy complex and expensive tools - they can simply send photos of embryos to a special laboratory and receive results in a matter of minutes.^[13]

IVF scandals

2019: Spouse sued 0.5 million rubles at a clinic in Moscow for IVF using the sperm of his wife's lover

In April 2019, it became known about the court decision, according to which the court ordered one of the Moscow clinics to pay about half a million rubles for dishonest IVF. The medical center used the sperm of the wife's lover instead of the biomaterial of the spouse.

Maxim and Yana Anokhin could not give birth to children for a long time. Eight IVF attempts were inconclusive, and the ninth procedure still led to the long-awaited conception - the couple had a son, Timothy.

Maxim Anokhin with Timofey, born from the sperm of his wife's lover Yana (also pictured)

But the family life of the spouses did not work out, they began to quarrel more and more often. Once, during another quarrel, the woman said that her lover was the boy's real dad.

Maxim Anokhin decided to pass a DNA test for determining paternity, and he confirmed that another person is the biological dad. It soon became clear that Yana wanted to use lover's sperm for IVF. Doctors not only did not object, but also advised the girl to resort to this method. According to Anokhin, this practice is not uncommon in fertility centers.

As I was told, the doctor replied: "You go to the left, your husband will not know about it... These are the doctors we have. And then people accidentally find out after a while that this could be the situation. Therefore, you can't guess if you will get to a decent or dishonest specialist, - said Maxim in an interview with the Moscow 24 TV channel.

Maxim Anokhin sued the clinic and won the case. He divorced and is married to another girl by April 2019. They had a son. The doctor who advised changing the sperm donor quit and moved to another medical institution.

According to Anokhin, he wanted his case to be widely publicized and perhaps help other men not to be in his place. So that there were no just deceived people, and such a mistake did not happen again, he said.^[14]

IVF risks

2022: Babies born from frozen embryos have increased cancer risk

On September 1, 2022, a study was published in which more than 8 million children from Scandinavian countries participated. It suggests that babies born after using an artificial insemination procedure known as frozen thawed embryo transfer may have a higher risk of developing cancer than babies born in other ways.

Assisted reproductive technologies (ART) allow the creation of an embryo from a human egg and sperm in the laboratory. The doctor can immediately transfer the embryo to the uterus, or, in accordance with a practice that is increasingly used around the world, the embryo can be frozen and then thawed before implantation.

Babies born from frozen embryos have increased cancer risk

Nona Sargisyan from the University of Gothenburg, Sweden, and her colleagues conducted a medical data analysis of 7,944,248 children in Denmark, Finland, Norway and Sweden. 171,744 children were born as a result of ART, and 7,772,474 children were conceived naturally. Of the babies born after ART use, 22,630 babies were born after transferring the frozen thawed fetus.

The results of statistical analysis of data from national medical registries showed that children born after transfer of a frozen thawed embryo are at higher risk of developing cancer, compared to children born after transfer of an unfrozen embryo and children born without ART. However, when the data were analyzed as a single group (i.e., children born after transfer of frozen thawed embryos and after transfer of fresh embryos), use of either ART species was not associated with an increased risk of cancer. The most common cancers observed in this study were leukemia and tumors of the central nervous system.

The researchers note that their findings should be considered with caution because, although the study was large, the number of children born after transfer of frozen thawed embryos who subsequently developed cancer was small (48 cases), which may have limited the statistical performance of the analysis.^[15]

Chronicle

2023

Why the popularity of IVF threatens a real epidemic of infertility

The growing popularity of in vitro fertilization (IVF) in the future could change the natural course of human evolution and provoke a real epidemic of infertility. This was warned in May 2023 by Dr. Hans Hanevik, head of the reproductive health department at the Telemark clinic in Norway.

IVF is most commonly used in the case of infertility. The process assumes that the egg is extracted from the woman's body and fertilized artificially "in a test tube." Further, the embryo, after a short stay in the incubator, is transferred to the uterine cavity for further development. In the course of such manipulations, Hanevik states, defective genes that usually die along with the carrier can be inherited. As a result, future generations with a high degree of probability will also not be able to independently conceive children. Thus, sooner or later the problem can affect all of humanity, and couples simply will not be able to acquire offspring without assistance.

IVF threatens a real epidemic of infertility

IVF is not only a fertility treatment, but also a technological intervention in the stage of a person's life cycle when natural selection acts most strongly. Although this is a great medical achievement, it allows you to bypass a number of reproductive barriers, "says Hanevik.

However, other experts emphasize that infertility is not always associated with defective genes. For example, in women, conception may not be possible due to the blockade of the fallopian tubes due to appendicitis, and in men - due to undescended testicles. In such situations, modern medical technology can help many people who would otherwise be forced to remain without their own children forever.^[16]

The first children from three parents were born

On May 9, 2023, it became known that the first children from three parents were born in Britain. This was made possible by the application of a new artificial insemination procedure aimed at preventing the inheritance of genetic diseases.

We are talking about an advanced method of in vitro fertilization (IVF). It helps prevent the development of mitochondrial diseases in the baby - hereditary ailments associated with defects in the functioning of mitochondria (provide vital energy for cells). Most often, such diseases affect the brain, heart, muscles and liver. The child's condition can steadily deteriorate as he gets older. Often such ailments lead to death at an early age.

Babies inherit all of their mitochondria from the mother, so harmful mutations can affect any of the woman's babies. According to statistics, about one in 6,000 children suffer from mitochondrial disorders. The new IVF procedure minimizes risks. In the first step, the father's sperm is used to fertilize the mother's eggs and a healthy female donor. The nucleus with genetic material from the donor egg is then removed and replaced with material from the pair's fertilized egg. The resulting egg has a complete set of chromosomes from both parents, but carries healthy donor mitochondria instead of defective mother mitochondria.

Thus, a child from three parents is born. At the same time, more than 99.8% of the infant's DNA comes from the mother and father, while from the donor the child inherits only about 37 genes (0.2%).

Britain's Human Fertilisation and Embryology Authority (HFEA) said "fewer than five" children were conceived in the country using the new IVF procedure. Other details for privacy reasons were not disclosed.^[17]

2022: Twins born from embryos frozen 30 years ago

In November 2022, a married couple from the US state of Oregon had twins from embryos that were frozen 30 years ago. This may be the longest cryopreservation that led to a live birth.

Twins Lydia and Timothy were born on October 31. Lydia's weight after birth was 2.6 kg, and Timothy - 2.9 kg.

Twins born from frozen embryos

This is really God's mercy, because he supported us at every step, "says the father.

The embryos were frozen on April 22, 1992. The parents of the newborns - Phillip and Rachel Ridgeway - have four other children, aged eight, six, three and one.

The happy father, in a conversation with reporters, admitted that he had specially calculated: the embryos were frozen when he himself was only 5 years old.

It's, in a way, our older children, albeit the youngest, "he says.

The eggs and sperm were taken from an anonymous pair. After the IVF procedure, they were frozen.

For some reason, the couple decided to later donate the embryos to the National Donation Center in the expectation that they could be used by another family experiencing problems with childbearing.

Despite the fact that the Ridgeway couple have no such problems, they decided that they would "adopt" three donor embryos, which were later planted in the uterus of Philip's wife. Two transplants were successful.

According to the Cleveland Clinic, which is based on national data for 2016, the live birth rate of frozen embryos is 49%.

The National Center for Embryo Donation argues that the storage time of frozen embryos is not limited. In their statement, they expressed hope that the news of the birth of healthy children would push other couples to adopt children born from the embryo.

In 2020, a Tennessee couple had a daughter, who appeared from a 27-year-old donor embryo. The sister of this girl was born in 2017 from a 24-year-old embryo.^[18]

2021: IVF up 8.8% to 161,705 cycles

In 2021, 161,705 IVF cycles were carried out in Russia, which is 8.8% more than a year earlier. Such data in the Russian Association of Human Reproduction (RARCHA) led in September 2023.

According to the organization's statistics, the number of cycles of IVF with PGT (preimplantation genetic testing) was 16,808, which is 33% more than in 2021. The data were presented at the RARCHE International Conference "Reproductive Technologies Today and Tomorrow." The conference is held from September 6 to 9 in Nizhny Novgorod.

In 2021, 161,705 IVF cycles were carried out in Russia

PGT is the check of embryos for chromosomal abnormalities during IVF before transferring the embryo to the uterine cavity. According to international research, the use of PGT increases the effectiveness of IVF, and the frequency of pregnancy increases by more than 2 times. This is due to the fact that the doctor gets the opportunity not to transfer embryos that will not develop into a normal pregnancy.

Earlier, the Genetico center began introducing PGT called Embryotest in Practical Health. Since 2015, single reproductive scientists and IVF centers have begun to use this screening. Based on the data of the RARCHE in 2021, every 10th IVF cycle in Russia was done with PGT.

As noted in the Russian Association of Human Reproduction, in Russia, fertility treatment with IVF is at the level of developed countries. According to the RARCHE, "the number of IVF cycles per 1 million of the population" in the Russian Federation is growing, 2021 year it reached 1100 cycles/million, compared to 2014 year 665 cycles/million.

According to the World Health Organization for 2021, one in six couples in the world today, for one reason or another, cannot conceive a child naturally. Moreover, every year their number increases due to a deterioration in the general health of the population, an increase in stress levels, lifestyle changes - including a decrease in physical activity and later pregnancy planning.^[19]

Notes