This article presents the law regulation of assisted reproduction (ART) in Ukraine. It shows the strict indications and contraindications for regular in vitro fertilization in the frames of routine management of infertile couples as well as terms, conditions, selection criteria for egg donors and surrogates and strict legal restrictions for egg donation and surrogacy programs. One of the main ideas of this article is to ruin the myth that anyone can do everything he wants in ART in Ukraine without further legal consequences.
egg donation – legislation of ART – surrogacy – Ukrainian infertility management
One of the obvious advantages of globalization process is blurred borders in many fields of human activity and medicine is not an exception. This spreads the newest medical approaches all over the world and besides, gives an opportunity to receive highly qualified medical care in any country guaranteed by the best physicians. Recently, medicine, jurisprudence and marketing banded together in highly structured medical business, so economy now-a-day is prevailed over ‘medicine as an art’. Even assisted reproduction– the newest branch of endocrine gynecology – has been set up to implement recent marketing trends and laws.
The first ART – baby in Ukraine was delivered in Kharkiv, after successful in vitro fertilization (IVF) treatment performed by prof. Fedir Dakhno in 1991 followed by numerous IVF infants since that time. Thus Ukrainian reproduction faced with necessity of law regulation so the first regulatory acts in this field were issued by Ministry of Health of Ukraine in 2004 and are changed so far.
Legal regulation of ART in Ukraine
Main principles of ART medical care are presented in the Constitution of Ukraine in Article 123 of the Family Code and moreover are regulated by several Instructions and Acts of Ministry of Health of Ukraine. The Constitution of Ukraine allows regular infertility treatment for infertile couple and besides, egg donation and surrogacy under the strict medical indications.
Family Code of Ukraine, Article 123
IVF – treatment with the own genetic material of infertile couple is described in part 1 of the Article: If a spouse has delivered a baby that was conceived as the result of ART treatment, performed under the written consent of her husband, her husband is registered as a father of the baby.
Regulation of surrogacy treatment
Part 2: If the embryo, conceived by a married couple (a husband and a wife) as a result of ART treatment, is transferred into the organism of the other woman, this couple has become the parents of the baby.
Regulation of egg donation
Part 3: The married couple is registered as parents of the baby that is delivered by the spouse after the transfer into her organism the human embryo that was conceived by her husband and other woman, as the result of ART treatment.
Along with The Constitution of Ukraine there are Fundamentals of Health Legislation of Ukraine issued on 19.11.1992 with all current changes, where in Article 40 noted confidentiality of ART, Article 47 declares ‘Transplantation of organs and other human anatomical materials’ and in Article 48 conceptualizes ‘artificial fertilization and implantation of embryos’. However, on 16. 07. 1999 Verkhovna Rada of Ukraine has issued an Act on Transplantation of organs and other human anatomical materials. Under the scope of this Act the term (definition) ‘transplantation’ does not apply for genital glands, reproductive cells and live embryos. Moreover, it is noted in the Article 281 of the Civil Code of Ukraine that female of majority age or male of majority age with the medical indications has a right to undergo the infertility treatment by means of assisted reproduction under the legal terms and conditions.
This legal terms and conditions were initially described in the Act of the Ministry of Health of Ukraine № 24 issued on 04. 02. 1997: ‘Approval of terms and conditions of artificial fertilization, embryo (embryos) implantation and conduction methods’ that had being repealed and replaced on the 23. 12. 2008 by the Act № 771: ’Approval Instruction on methods of assisted reproductive techniques’.
This Instruction determines the terms and conditions of assisted reproduction and is mandatory for each ART Center in the country independently on the type of ownership. Each ART Center has to receive the state accreditation of ministry of Health of Ukraine as working permission. Female of majority age or male of majority age with the medical indications has a right to undergo the infertility treatment by means of assisted reproduction only after their written consent for the ART treatment and careful examination of their somatic and psychic health, hormonal and genetic testing and absence of contraindications for carrying pregnancy and delivery.
All somatic contraindications for carrying pregnancy and delivery are presented in the Act of Ministry of Health of Ukraine No 579 issued 29. 11. 2004 ’Direction for women with absolute IVF indication for the first attempt of ART treatment, guaranteed from the state budget’.
Somatic contraindications for carrying pregnancy according to International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD 10): severe forms of diabetes mellitus, severe forms of arterial blood hypertension and forms that are complicated with constant hypertension and kidneys failure, psychiatric diseases with the contraindications to carrying pregnancy and other.
At the first visit to ART Center special medical form, under the sample of this Act should be fulfilled for every couple or female patient. Prior to IVF treatment the patients should be carefully examined.
Examinations of patients prior IVF
Syphilis (microprecipitation reaction), Hepatitis B and C (general antibodies), HIV 1 and 2 types (in case of any positive test the patient should be directed to corresponding specialist for further examination and treatment) – these exams are valid within 3 months period of time; blood type and Rh ID (have no time validity); karyotype and other genetic testing (have no time validity).
Partner has to pass through spermiogramm and consulted by urologist.
Female should be tested at: TORCH infections, complete blood count, coagulation tests, blood biochemistry (ALT, AST, bilirubin, urea, creatinin, general protein, glucose level, CRP), urine microscopy, urogenital swab, Pap smear, Chlamydia trachomatis, immunological screening for antiphospholipid and antispermal antibodies, basal hormonal screening, mammological report and therapeutic report on her possibility to carry pregnancy.
Protocols of ovarian stimulation
After the careful examination and preparation the female starts the controlled ovarian hyperstimulation with the help of different types of pharmacological substances chosen by her ART specialist from the allowed list ( selected modulators of estrogen receptors, aromatase inhibitors, gonadotropins: human menopausal gonadotropin, follicle-stimulated hormone, recombinant follicle-stimulation hormone, recombinant luteinizing-stimulation hormone, human chorionic gonadotropin, agonists of gonadotropin releasing hormone and antagonists of gonadotropin releasing hormone).
The final criteria for triggering ovulation are 3 or more follicles over 18 mm and endometrial thickness over 8 mm. In 35–36 hours after the triggering the oocyte retrieval (OR) is performed in aseptic condition with the support of vaginal ultrasound in short-timing general anesthesia, and the patient is able to leave clinic after at least 2 hours of observation. The fertilization of oocytes is performed within maximum 6 hours after the OR. The fertilization techniques are chosen by embryologist on semen and oocyte quantity and quality.
The embryo transfer (ET) is allowed at any cleavage stage from zygote to blastocyst. There are legal prescriptions to transfer 1–2 embryos into the uterine cavity with the only exception in case of predictable poor implantation chances when it is allowed to transfer maximum 3 embryos on patients’ written request. The rest embryos may be frozen on patients’ written request for further cryo embryo transfer.
All manipulations with sperm, oocytes and embryos are matched into special journals (OR, IVF manipulation, semen analysis, cryo semen, cryo oocytes, cryo embryos, donor’s semen, donor’s oocytes and insemination with partner’s or donor’s semen journals) according to this Act.
The luteal phase support
The luteal phase is supported by gestagens or their analogs. If there is no risk of ovarian hyperstimulation syndrome (OHSS) it is possible to maintain the luteal phase also with human chorionic gonadotropins from the day of ET 2–4 times with the intervals of 2–4 days. The dosage and type of medicine for the luteal support is prescribed individually for each patient.
There are also strict indications for egg donation programs and egg donors’ theirselves.
Indications for Recipients:
- the complete absence of oocytes due to natural menopause
- premature ovarian failure syndrome
- status post ovarioectomy, ray- or chemo-therapy
- congenital malformations of genital organs (gonad disgenesie, Turner’s syndrome)
- high risk sex-linked inherited congenital diseases (hemophilia, Duchenne's myodystrophy, ichthyosis, amyotrophy of Sharko-Mari-Tutt)
- recurrent IVF failures (4 and over) with insufficient ovarian response on ovarian stimulation, and recurrent low embryo quality.
Requirements for Egg Donors
The Egg Donors may be:
- Relatives or other familiar women
- Anonymous voluntary Egg donors
- IVF patients who share their own oocytes with other ART patients by their written consent
All of them should fit the requirements:
- women from 20–32 years, in satisfactory somatic health
- has delivered a healthy child (excluding IVF patients who share their own oocytes)
- with the absence of negative phenotypic features
- with the absence of contraindication for the egg donation program
- with the absence of inherited diseases
- with the absence of any kind of addiction: narcotic drugs, alcohol, etc.
All gamete donors cannot put parental responsibility on a future child. The gamete and embryo donation is performed on the written consent of egg donors, semen donors or embryo donors.
The semen donors may be men from 20–40 years in satisfactory somatic health which has his genetic child with the absence of negative phenotypic features, inherited diseases and any kind of addiction: narcotic drugs, alcohol, etc.
The Embryo donors may be patients by written consent who have unused cryo preserved embryos in a cryo bank after the delivery of their child.
Indications for the use of donor’s semen are:
- infertility (azoospermie)
- ejaculatory-sexually disorders
- poor genetic prognosis
- when it is impossible to conceive naturally
- woman’s wish
Indications for recipients for surrogacy program:
- the absence of womb (congenital or after hysterectomy)
- deformation of the cervix or uterine cavity due to congenital malformation or as a result of disease that disable carrying pregnancy
- incurable adhesions of the uterine cavity
- severe somatic diseases that could not afflict the future child’s health but may be dangers to his mother
- recurrent IVF failure (4 and over) with the constant high quality embryos, with no pregnancy resulted
Who can be the surrogate mother?
It should be the mature of age capable woman with her own healthy child on her own written consent and with absence of medical contradictions for the procedure due to Act of Ministry of Health of Ukraine No 579 issued 29. 11. 2004 “Direction for women with absolute IVF indication for the first attempt of ART treatment, guaranteed from the state budget”.
The pregnancy observation for the surrogate mother is due to Act of Ministry of Health No 417 issued 15. 07. 2011 as for regular pregnant women. The juridical procedures are described above in this article. It is possible to perform the surrogate program only for countries where is Surrogacy is legal.
On the 09.09.2013 Ministry of Health of Ukraine has issued new Act № 787 `Use of Assisted Reproductive Techniques in Ukraine', that disable the previous Act № 711, issued 23.12.2008. The new Act № 787 provides detailed information on basic laboratory and medical equipment necessary for ART. Besides, it expands the age of egg donors up to 36 years.
To conclude I would like to remind that all ART procedures in Ukraine are allowed only under the strict legal conditions. It is possible to use flexible individual stimulation protocol with a large variety of GnRH antagonists and antagonists. Besides it is important to mention that there is no medical insurance for ART procedures in Ukraine, and patients must cover all the expanses by themselves that force Ukrainian ART specialists to become more flexible and patient oriented. The average pregnancy rate is about 40 % for IVF/ICSI and around 60 % for Egg Donation programs.
Doručeno do redakce dne 10. září 2013
Přijato po recenzi dne 7. listopadu 2013
Nataliya Kushniruk, M.D.
Department of Obstetrics and Gynecology, Assisted Reproduction Centre, 1st Medical Faculty of Charles University in Prague
Reproductive Genetics Clinic ‘Victoria’, Kiev, Ukraine