Traditional Surrogacy
Gestational Surrogacy
Gestational Surrogacy + Egg Donation

Surrogates
Egg Donors
Sperm Donors

Toward using assisted reproductive technologies (ART)
in the therapy of women’s and men’s infertility

For the purposes of regulation and introduction of new assisted reproductive technologies in the activity of medical organizations was ordered:

1. To approve:

• The instruction for using methods of assisted reproductive technologies (addendum №1).
• Individual card of the patient who uses methods of assisted reproductive technologies –f. № 111-1/y-03 (addendum №2).
• Individual card of sperm donor – f. № 158/y-03 (addendum №3).
• Individual card of oocytes donor - f. № 158-1/y-03 (addendum №4).
• Registry of record for storage and using patient’s sperm – f. № 158-2/y-03 (addendum №5).
• Registry of record for storage and using donor’s sperm – f. № 158-3/y-03 (addendum №6).
• Registry of record for storage and using patient’s oocytes – f. № 158-4/y-03 (addendum №7).
• Registry of record for storage and using donor’s oocytes – f. № 158-5/y-03 (addendum №8).
• Registry of record for storage and using cryoconserved embryos – f.№ 158-6/y-03 (addendum №9).
• Registry of performing artificial inseminations (AI) – f. № 158-7/y-03 (addendum № 10).
• List of forms of primary medical documentation with the period of storage (addendum №11).
• Recommended  structure, list of equipping of ART center (addendum № 12).

2. To consider the Health of Ministry Order, December 28, 1993 №301, “Toward using the method of artificial insemination with donated sperm due to medical indications and the method of in vitro fertilization and embryo transfer in the cavity of uterus for treating of women’s infertility” (registered by Ministry of Justice of Russia on January 10, 1994, registration number is 453) is not effective any longer.

3. To give the deputy Minister of health of Russian Federation O.V.Sharapova the control over this order execution.

Minister
U.L. Shevchenko

Addendum №1
Russian Federation of Ministry of Health order
26.02.2003 №67

Instruction
toward using the methods of assisted reproductive technologies

ART – are the methods for infertility treatment, whereby separate or all stages of conception and early development of embryos are implemented outside the organism. ART include: in vitro fertilization and embryos transfer to the cavity of uterus, intracytoplasmic sperm injection, sperm donation, oocytes donation, surrogate maternity, preimplantationed diagnostic of inherited diseases, artificial insemination by husband’s sperm (donor’s).
Performing  ART is possible only at the presence of written informed agreement of patients.

1. In vitro fertilization.
……………………………………………

2. Intracytoplasmic sperm injection
……………………………………………

3. Surgeon methods of spermatozoids retraival.
……………………………………………

4. Assisted hatching.
……………………………………………

5. Pre-implantation diagnosis of inherited diseases.
……………………………………………

6. Donation of gametes and embryos. 

Donors of gametes donate their gametes (sperm, oocytes) to other people to overcome their infertility and don’t take upon themselves parents obligations in regard to future child. The birth of 20 children from one donor on 800 thousands of region’s population is the foundation to not use this donor for recipients of this region.

6.1. Оocytes Donation.

Oocyte donor can be:

• non-anonymous relatives or women who are known to the recipient;
• anonymous donors.

Donation of oocytes is performed at the presence of donor’s written informed agreement on undergoing the procedures of induction of superovulation and puncture of ovaries.
Oocyte donor requirements:

• Egg donors are between the ages of 20 and 30;
• Egg donors have at least one child of her own;
• The manifestation of a phenotype traits must not be expressed;
• Egg donor candidate is mentally and physically healthy person.

Indications for IVF with using donor’s oocytes:

• No oocytes (eggs) are presented due to natural menopause, premature ovarian failure, condition after ovariectomy surgery, radio- or chemotherapy, as well as congenital malformations like gonadal dysgenesis, Shereshevscky-Turner syndrome, etc;
• Functional inferiority of oocytes in women with sex-linked hereditary diseases like hemophilia, myodystrophy, X-linked ichthyosis, peroneal myatrophy, etc;
• Multiple failed IVF cycle due to poor ovarian responds to hormonal stimulation, recurrent unsuccessful transfer of low-quality embryos.

The same when IVF procedure is.
Observations for oocytes donors:

• Determination of blood type and Rh factor;
• Internist observation to determine health condition and that surgical operation is not medically contra-indicated (valid 1 year);
• Examination and conclusion of psychiatrist (run);
• Genetic consultation– clinico-genealogical examination, chromosome analysis and others due to indications;
• Gynecological examination (before each attempt of hormonal stimulation);
• General analysis of urine;
• Electrocardiogram (valid 1 year);
• Clinical and biochemical blood test, analysis on blood coagulation before each attempt of hormonal stimulation;
• Blood test on syphilis, HIV, hepatitis B and C (3 months valid);
• Pap smears (before each attempt of hormonal stimulation);
• Detection of infections: gonorrhea, chlamydiosis, genital herpes, ureaplasmosis, mycoplasmosis, cytomegaly (65 months valid);
• Cytological examination of smears from uterine neck;
• Fluorography (1 year valid).

Observations for married couple (recipients).
The same those are undergone for IVF procedure.
Documentation necessary for work on “Oocyte donation” program:

• written informed agreement of oocytes donor;
• questionnaire  of oocytes donor;
• individual card of oocytes donor;
• catalog of oocytes donors with description of anthropometric data and phenotypic portrait, which is offered to the patients.

Donor’s questionnaire is filled in and coded by the doctor. The scheme of coding- is free.
All the documents about oocytes donation are kept in the safe as the documents that are restricted.
The doctor deals with donors. The doctor performs medical examination for donor before every IVF attempt, executes control over holding laboratory researches and their results timely in regard with calendar plan of observation.

“Oocytes donation”  is performed according the following scheme:

• choosing of oocytes donor;
•  synchronization of menstrual cycles;
• in vitro fertilization.

6.2. Sperm donation

Sperm donor can be used for IVF and AI (artificial insemination). Indications for using sperm donor are described in appropriated sections. It is acceptable to use sperm donated in other institutions that have sperm bank.
It is permitted to use frozen/defrosted sperm only after getting repeated (in 6 months after handing over the sperm) negative results on IVF, syphilis and hepatitis analysis. Using of frozen / defrosted sperm allows to:

• prevent transmission of HIV, syphilis, hepatitis and other infections;
• exclude possibility that donor and recipient meet each other.

Sperm donor requirements:

• age between 20 and 40;
• absence of deviation in normal organomethric and phenotypic traits.

Donated sperm requirements:

•  volume of ejaculate is more than 1 ml;
• concentration of spermatozoids in 1 ml of ejaculate is more then 80 millions;
• quantity of progressive-mobile forms (A+B) is more 60%;
• quantity of morphological-normal forms is more 60%;
• cryotolerance.

Observation for sperm donors:

• determination of blood type and Rh factor;
• internist observation to determine health condition (once a year);
• urologist observation (once a year);
• psychiatrist observation (run);
• medico-genetic observation (clinicogenealogical investigation, karyotyping and other under indications);
• blood test on syphilis, HIV, hepatitis B and C (valid for 3 months);
• detection of infections:: gonorrhea, chlamydiosis, genital herpes, ureaplasmosis, mycoplasmosis, cytomegaly (valid for 6 months);

Required documentation for donated sperm bank:

• application of sperm donor;
• individual card of sperm donor;
• registry of record of storage and using donated sperm;
• catalogue of sperm donors with the description of anthropometric data and phenotypic portrait.

Individual donor’s card fills in and coding by the doctor. The scheme of coding is free. Application of donor and his individual card are kept in the safe as the documents that are restricted.
The doctor and the embryologist deal with the donors.
The doctor organizes medical examinations of donor, executes control on holding laboratory explosions and their results timely in regard with calendar plan of observation.
The embryologist implements freezing and defrosting of sperm, estimate the quality of sperm before and after cryoconservation, provides necessary regime of sperm storage, keeps record of material.
Extraction and registration of donated sperm.
Continence for 3-5 days is recommended before sperm extraction. Extraction of sperm implemented through masturbation. Ejaculates are gathered in special sterile, preliminary marked capacity. This procedure takes place in special room with separate entrance and washstand.
Donated sperm is registered in the registry of revenue of donated sperm and in the card of receipt and expenditure of donor’s sperm.
6.3. Embryo donation  
Donors of embryos can be patients of IVF program, who after completion of their family (birth a child) remain not used cryoconservated embryos in bank. By free decision and written informed agreement of patients-donors these embryos can be used by infertile married couple or by unmarried women (recipients).
Embryos for donation can be created through insemination of donated oocytes by donated sperm.
Patients must be informed that effectiveness of IVF program is lower when left by the patients cryoconserved embryos are used, than if the patients use embryos created with donated gametes. Recipients must be provided with phenotypic portrait of the donors.

Indications for IVF program with donated embryos using:

• recipients do not have oocytes;
• genetic diseases;
• low quality embryos; a number of embryo transfer attempts that didn’t result in  pregnancy;
• impossibility of extraction or using of husband’s sperm in addition to above-mentioned factors (and other factors).

When IVF program with donated embryos is medically contra-indicated::
The same when IVF procedure is.
Observation for recipients:
The same as to hold IVF procedure, and it is also necessary to make medical examinations to recognize the pregnancy that is developing spontaneously.
Guidelines for choosing embryo donors.
They are the same as for donors of gametes.
Observation for embryo donors.
Married couple decided to donate its embryos should undergo observation required for the gametes donors.

6.4. Cryoconservation of sperm, oocytes, embryos and biomaterial retrieved from testicle.

Cryoconservation of sperm and oocytes.
It is possible to cryoconservate sperm and oocytes only if there is written application – informed agreement.
The method of sperm and oocytes freezing and defrosting depends on cryoprotectors, available equipment and every laboratory chooses it independently.
If it is the first time sperm cryoconservation, it’s necessary to make control freezing /defrosting of sperm. The patient / donor should be informed of results of control investigation.
Cryoconservation of embryos.
To hold the process of cryoconservation programmed freezer or vitrification are used. The stage of embryo’s developing and the type of cryoprotector determine the program of cryoconservation.
Frozen embryos are storied in special marked plastic straws, placed in liquid nitrogen.
Cryoconservation of biological material retrieved from the testicle or its appendage.
If there are spermatozoids in biological material, it is to be frozen for following use in IVF-ICSI program. The procedure of freezing is the same as if it is sperm cryoconservation.

7. Surrogacy.

<*> Summary of legislation of Russian Federation, 01.01.1996, № 1, art.16.
<**> Summary of legislation of Russian Federation, 24.11.1997, № 47, art.5340.

Married couple and surrogate mother give written informed agreement on participation in surrogacy program.
Indications for surrogacy:

• No uterus (from birth or acquired);
• Uterine synechiae;
• Deformation of uterine cavity or deformation of uterine neck;
• Somatic diseases that are the reason the full-term pregnancy is medically contra-indicated;
• Multiple failed IVF cycles.

Surrogate mothers can be women who voluntary agreed to participate in this program.
Surrogate mothers requirements:

• Age between 20 and 30 years of age;
• Surrogate candidate has delivered and is raising at least one child of her own;
• Surrogate candidate is mentally and physically healthy person;

Medical screening for  surrogate mothers:

• Determination of blood type and Rh factor;
• Blood test on syphilis, HIV, hepatitis B and C;
• Detection of infections: chlamydiosis, genital herpes, ureaplasmosis, mycoplasmosis, cytomegaly, Rubella titre;
• General analisis of urine;
• Clinical analysis of blood and blood coagulation test;
• Biochemical blood test: enzymes ALT (alanin - aminotransferase) and AST (aspartat - aminotransferase), bilirubin, sugar, urea;
• Fluorography;
• Pap smear;
• Cytological analysis of smears from uterine neck;
• Internist observation to determine health condition and that full-term pregnancy is not medically contra-indicated;
• Examination and conclusion of psychiatrist;
• General and special gynecological examination (before each attempt of hormonal stimulation).

Contraindications for IVF and ET in surrogacy program and medical screening for married couple are the same as for IVF program.
Surrogacy program is held on the following algorithm:

• choosing of surrogate mother;
• synchronization of menstrual cycles;
• procedure of in vitro fertilization with embryo transfer to the uterus’s cavity of surrogate mother.

8. Embryo transfer.
……………………………………………………

9. Artificial insemination by husband’s / donor’s sperm.

Artificial insemination (AI) can be held by the mean of introduction of sperm to the cervical canal or to the uterus cavity. Procedure can be executed both in natural menstrual cycle and with using inductors of superovulation.
If artificial insemination by donated sperm is held it is possible to use only cryoconserved sperm.
Using of native sperm at AI by husband’s sperm is permissible.
Indications for AI by donor’s sperm:
male:

• infertility;
• ejaculative-sexual disorders;
• genetic diseases;

female:

• no sexual partner.

Indications for AI by husband’s sperm:
male:

• subfertile sperm;
• ejaculative-sexual disorders;

female:

• cervical factor of infertility;
• vaginitis.

Contraindications AI:
female:

• somatic and psychic diseases due to which pregnancy is medically contra-indicated;
• defects of development and pathology of uterus, due to which full-term pregnancy is impossible;
• tumors and tumorable formations of the ovary;
• malignant new formations of any localization;
• inflammatory diseases of any localization;

Medical screening for married couple before holding AI:
The same when IVF is used.
Methodology of holding AI.
The patients decide to use AI on doctors recommendations that depend on quantitative and qualitative characteristics of ejaculate.
AI can be used both in natural cycle and in hormonal stimulated cycle.
Slipping sperm in is realized in preovulatory period.
For AI can be used native, preliminary prepared or cryoconserved husband’s sperm, and also cryoconserved donor’s sperm. The doctor determines quantity of AI attempts.
Complications that can arise due to AI:

• allergic reactions, connected with hormonal stimulation;
• shock reaction at slipping sperm in to the uterus cavity;
• syndrome of hyperstimulation of the ovaries;
• inflammation or flare of chronic inflammation of woman’s genital system organs;
• multiple and / or ectopic pregnancy.