Thông tư 57/2015/TT-BYT về sinh con bằng kỹ thuật thụ tinh trong ống nghiệm

THE MINISTRY OF HEALTH

Circular No.57/2015/TT-BYT dated December 30, 2015 of the Ministry of Health detailing a number of articles of the Decree No. 10/2015/ND-CP dated January 28, 2015 of the Government on giving birth through in vitro fertilization and conditions for altruistic gestational surrogacy

Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 by the Government defining the functions, tasks, entitlements and organizational structure of the Ministry of Health;

Pursuant to Decree No.10/2015/ND-CPdated January 28, 2015 by the Government on in vitro fertilization and conditions for surrogacy for humanitarian reasons;

At the request of Director of Department of Maternal Health and Children;

The Minister of Healthhereby promulgates the Circular detailing a number of articles of Decree No.10/2015/ND-CPdated January 28, 2015 of the Government on giving birth through in vitro fertilization and conditions for altruistic gestational surrogacy.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Circular provides for health standards for people who adapt the in vitro fertilization service, have pregnancy or give birth; facilities, equipment and staff of medical facilities permitted to carry out the in-vitro fertilization technique; procedures for examination and diagnosis of infertility; technical process of in vitro fertilization; retention and sharing of information.

Article 2. Subject of application

This Circular applies to qualified medical facilities prescribed in Decree No. 10/2015/ND-CP dated January 28, 2015 by the Government on in vitro fertilization and conditions for surrogacy for humanitarian reasons (hereinafter referred to as Decree No.10/2015/ND-CP)and relevant agencies, organizations and individuals.

Chapter II

STANDARDS FOR HEALTH OF PEOPLE WHO ADAPT THE IN-VITRO FERTILIZATION TECHNIQUE; FACILITIES, EQUIPMENT AND STAFF OF MEDICAL FACILITIES CARRYING OUT THE IN VITRO FERTILIZATION

Article 3. Standards for health of people involved in in-vitro fertilization technique

1.Any person involved in in-vitro fertilization must not have the following diseases: diseases that make his/her health unsatisfactory for in-vitro fertilization, for having pregnancy or giving birth; sexually transmitted diseases, HIV or group A/B infectious diseases; hereditary diseases that may affect life and the development of the child; mental illness or other diseases that makes him/her unable to have awareness or direct his/her behavior.

2.Any person involved in in-vitro fertilization technique must obtains a written conclusion by the head of a medical facility qualified for carrying out the in-vitro fertilization certifying that his/her health conditions is suitable for involving in in-vitro fertilization procedures, for having pregnancy and giving birth.

Article 4. Standards for facilities of medical facilities carrying out the in vitro fertilization

1.There shall be facilities specialized for care of premature babies, for intensive care and for technique of reproductive endocrinology testing that can produce result in the day.

2.There shall be separate area for the conduct of in vitro fertilization with a minimum area of 500 m2(including the path area) and the following rooms:

a) Room for receiving patients;

b) Consulting room for men and women;

c) Room for egg retrieval;

d) Room for retrieval of sperms;

dd) Fertilization laboratory;

e) Ultrasound room;

g) Room for testing sperm washing satisfying standards recommended by World Health Organization.

Article 5. Standards for medical equipment of medical facilities carrying out the in vitro fertilization

Any medical facilities carrying out the in vitro fertilization must be fully equipped with the following equipment:

Article 6. Standards for staff of medical facilities carrying out the in vitro fertilization

Any person directly carries out the in vitro fertilization must satisfy the following requirements:

1.He/she shall obtain qualifications in in-vitro fertilization technique (recognized qualifications of trade in in-vitro fertilization technique, applicable to staff members receiving training from overseas qualified establishments under similar or higher conditions than those in Vietnam.

2.He/she shall obtain certificates of having directly carried out at least 20 (twenty) cycles of infertility treatment using in-vitro fertilization technique.

3.He/she shall obtain a practice certificate according to regulations in the Law on Medical examination and treatment.

Chapter III

INFERTILITY EXAMINATION AND DIAGNOSIS PROCEDURES

Article 7. Examination and testing for infertility for couples

1.Requirements: Ask about health conditions and conduct physical examination for both husband and wife.

2.For the wife

a) Clinical examination:

-Internal and external examinations;

-Gynaecological examinations, breast examinations.

b) Subclinical examination:

-Assessment of the ovarian reserve by counting the secondary follicles or via AMH testing;

-Survey of operation of ovary via endocrine testing, when necessary;

-Inspection of the smoothness and the operation of the oviduct;

-Testing of formula of blood, biochemical testing of blood;

-Testing for B hepatitis; syphilis, tuberculosis, HIV (patients must be provided with information about HIV testing before and after HIV testing according to law provisions on HIV/AIDS prevention), Chlamydia;

-Scanning for cervical cancer using HPV, pap test;

-Other special testing (depending on conditions of specific patient):Cytomegalo virus, Antiphospholipid, mammography, genetic testing.

3.For the husband

a) Semen analysis, according to guidelines of WHO;

b) Testing:

- Testing for B hepatitis; syphilis, tuberculosis, HIV (patientsmustbe provided with information about HIV testing before and after HIV testing according to law provisions on HIV/AIDS prevention);

c) When necessary or in case of irregular signs:

-Internal examination;

-Genital examination;

-Other additional examinations as the case may be.

Article 8. Examination and testing for infertility forsingle ladies

Single ladies shall received physical examination and testing as prescribed in Clause 2 Article 7 of this Circular.

Chapter IV

IN-VITRO FERTILIZATION PROCEDURES

Article 9. Consultation for couples involved in vitro fertilization

Couples shall be provided with the following information:

1.Treatment procedures, including clinical examinations, subclinical examinations, testings, ovarian stimulation regimen, time for using drugs, supervision during the treatment with drugs.

2.Expected time for retrieving eggs and time for collecting sperms.

3.Expected time for embryo transfer, embryo storage capacity in case of risk of ovarian hyperstimulation syndrome or in case the endometrium is not suitable.

4.Luteal phase, supervision after embryo transfer.

5.Success rate of in-vitro fertilization technique.

6.Possible accidents.

7.Treatment cost.

Article 10. Consultation about special cases

1.For in vitro fertilization with borrowed eggs

a) People involved in in-vitro fertilization with borrowed eggs are usually old women, women with premature ovarian failure, unhealthy or irregular ovary due to the heredity;

b) Besides information that must be provided for couples specified in Article 9 of this Circular, the following additional information shall be provided:

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-Procedures of ovarian stimulationand supervision towards egg donors;

-The transfer procedures: egg receiver may take endometrium preparation drugs at the same time the egg donor received ovarian stimulation so that the fresh embryo or the embryo made from eggs of the donor can be transferred, and sperms of the husband shall be totally frozen, and the egg receiver shall receive the transferred embryo right then;

-Success rate of the fertilization, depending on the age of the egg donor and the ability to accept the embryo of the receiver;

-The heredity characteristics of the child;

- Accidentfrom egg retrieval that the egg donors may meet.

The egg-receiver and her husband and the egg donor shall sign a commitment.

2.For in vitro fertilization carried out because the husband does not have sperm:

a) The procedure that the husband shall receive a testicle aspiration or a percutaneous epididymal sperm aspiration to determine whether there is sperm; if there is, his sperm can be used for in vitro fertilization;

b) The information about the sperm collection procedures with testicle aspiration or percutaneous epididymal sperm aspiration, then the in vitro fertilization by intra-cytoplasmic sperm injection (ICSI) shall be conducted;

c) The success rate, costs;

d) Possible accidents;

dd) The use of sperm sample of the donor in case the physician fails to collect sperms of the husband;

e) The heredity of the child in case of sperm borrow.

3.For in vitro fertilization with borrowed embryos: as prescribed in clause 1 of this Article.

4. For in vitro fertilization with borrowedsperms for single ladies

Besides information that must be provided for couplesprescribedin Article 9 of this Circular, theinformation about the heredity of the child shall be provided.

Article 11. In vitro fertilization procedure (IVF)

1.In vitro fertilization (IVF) is a childbirth assistance technique where sperms are enable to inseminate eggs outside the body (in vitro). Embryos from such insemination shall be collected and frozen or transferred to uteruses.

2.Procedures:

a) Conduct physical examination and necessary examinations for couples;

b) Make assessment of ovarian reserve;

c) Carry out the ovarian stimulation;

d) Supervise the development of follicles;

dd) Inject substances promoting the development of follicles when suitable;

e) Retrieve egg through the vagina with the assistance of ultrasound machines;

g) Assist the luteal phase, for fresh embryo transfer;

h) Collect sperms of the husband and prepare the sperms;

i) Let the sperms inseminate eggs according to the traditional in vitro fertilization (IVF) or according to intra-cytoplasmic sperm injection (ICSI);

k) Conduct the incubation in the CO2incubator;

l) Inspect the insemination of eggs;

m) Grow the embryo and supervise its development;

n) Embryo transfer: using 2nd-date embryo, 3rd-date embryo or 5th-date embryo (blastula), depending on treatment regimen of specific facility carrying out the in vitro fertilization;

o) Continue assisting the luteal phase, for fresh embryo transfer;

p) Conduct a pregnancy test using bhCG serum;

q) Conduct an ultrasound scan of the vagina to determine the development and location of the fetus.

Article 12.Procedures for preparing sperms for in vitro fertilization procedure

1.Preparing sperms is a technique to separate the most efficient sperms from damaged sperms and fluid for in-vitro insemination.

2. Procedures

a) Collection of seminal fluid:

-The husband shall abstain from sex for 3 to 7 days before the sperm collection;

-Tools shall be prepared for processing sperm samples, different sets of tools for different persons, wearing names or code numbers of the couple;

-Sperms shall be collected from the masturbation. Hands and sex organs shall be cleansed before the collection.

b) Sperm preparation:

-The sperm sample shall be put in the warmer and wait until it totally lyses, record the time it totally lyses;

-An amount of seminal fluid shall be taken for the assessment of general indicator;

-Sperms shall be prepared by basic techniques;

-Sperms collected after the preparation are used for IVF or ICSI.

Article 13.Egg retrievalfor in vitro fertilization procedure (IVF)

1.Egg retrievalis a technique where eggs are retrieved via vaginal ultrasound and enable to inseminate sperms outside the body.

2. Procedures:

a) The patient shall be injected the analgesic for systemic anaesthesia or partial anaesthesia, or combined with pre-medicated anaesthesia;

b) The patient shall abstain from food before egg retrieval and shall urinate before the procedure;

c) Vulva, vagina and cervix shall be cleansed with physiological saline;

d) Feet and belly shall be covered with a surgical towel;

dd) Needles shall be coated with egg retrieval environment before egg retrieval;

g)Eggs shall be retrievedwith the assistance of ultrasound machines;

h) The retrieved follicular fluid shall be sent to laboratory for egg collection;

i) Needles shall be cleansed carefully.

3.Post-retrieval supervision

a) The wife shall rest in the room for egg retrieval after the retrieval;

b) Pulses, blood pressure, breathing of the wife and that whether the wife has bellyache or not and whether her vagina bleed or not shall be supervised;

c) The wife shall be provide with guidance on using drugs, date of embryo transfer (in case of fresh embryo transfer).

Article 14. Embryo transfer procedures

1.Embryo transfer is a technique where one or multiple embryos are transferred to the uterus of the receiver to grow.

2. Procedures:

a) The embryo subject to transfer shall be prepared on a plate, code of the embryo, names and ages of the embryo donor and receiver and number of the dossier shall be carefully compared;

b) The receiver shall abstain from urinating to make the bladder strain;

c) The patient shall lie in a posture for gynaecological examination;

d) The vulva shall be cleansed;

dd) The cervix shall be opened with a speculum and cleansed with embryo transfer environment;

e) The outer part of the catheter shall be threaded through the cervix tube to the cervical canal;

g) When the outer part of the catheter has been threaded to the cervical canal, everything shall be prepared for sucking the embryo into the inner part of the catheter;

h) The inner part of the catheter carrying the embryo shall be lightly threaded to the uterus, its head shall be about 2 cm distant from the bottom of the uterus;

i) The embryo shall be lightly pumped to the uterus;

k) The catheter shall be lightly taken out of the uterus;

l) The catheter shall be checked whether the embryo has been fully pumped to the uterus;

m) The speculum shall be removed;

n) The patient shall rest at least 30 minutes before she left the room;

o) The luteal phase assistance shall be conducted.

Article 15. Intra-cytoplasmic sperm injection (ICSI)

1. Intra-cytoplasmic sperm injectionis a minor surgical technique where a sperm is directly injected into the cytoplasm of an egg to inseminate.

2. Procedures:

a) Sperm samples shall be prepared for ICSI;

b) Retrieved eggs shall be stored in the warmer before the procedure;

c) Plates shall be prepared for ICSI;

d) The microscope and tools for the procedure shall be prepared;

dd) The egg-cell shall be separated;

e) The sperm shall be injected into the cytoplasm of the egg;

g) The egg containing the injected sperm shall be kept in the CO2incubator;

h) The insemination shall be inspected.

Article 16. Sperm-collecting procedures

1.Sperm-collecting procedure is a technique where sperms are retrieved from the epididymis or the testicle aspiration and used for inseminating with the egg through the ICSI technique, applicable to case where the semen does not contain a sperm or the sperms cannot be ejaculated.

2. Procedures:

a) The patient shall be injected the analgesic for systemic anaesthesia or partial anaesthesia;

b) The sex organ and the nearby area shall be cleansed with physiological saline;

c) The epididymis/testicle shall be fixed;

d) The percutaneous epididymal sperm aspiration or testicle aspiration shall be conducted;

e) The pathology specimens shall be looked for.

g) Sperms shall be prepared from the pathology specimens or separated from the testicle tissue;

h) The patient shall be provided with guidance on post-operation care.

Article 17. Procedures for cold storage of sperms

1.The cold storage of sperm is a technique where the sperm sample is frozen and stored in a cold storage environment. Such sperm can be defrosted for use when necessary.

2.Slow freezing:

a) An assessment of sperm quality shall be conducted according to the standards of WHO;

b) Sperms shall be mixed with the freezing substances;

c) The sperms shall be packed; name of the patient, code and date of freezing must be written on the package;

d) The temperature shall be dropped;

dd) Samples shall be stored in liquid nitrogen.

Article 18. Procedures forsperm thawing

1.Sperm thawing is a technique where the sperms frozen and stored in the storage are defrosted and washed for use.

2.Procedures:

a) The vial containing the sperms shall be taken out of the liquid nitrogen;

b) The vial shall be soaked in 37oC water;

c) The container shall be opened and the frozen sperms shall be taken;

d) An assessment of quality of sperms after freezing shall be conducted;

dd) Thawed sperms shall be prepared for use.

Article 19. Procedures for cold storage of testicle tissues

1.Cold storage of testicle tissue is a technique where the testicle tissues are aspirated, then sperms are found, frozen and stored in freezing environment.Suchtesticle tissuescan be defrosted fortaking sperms foruse when necessary.

2. Procedures:

a) Examinations, testing and consultation shall be conducted in accordance with those of sperm-collecting procedures

b) Testicle tissues shall be aspirated and laid on plates containing washing environment;

c) Testicle tissues shall be cut into small pieces with specialized tweezers, the appearance of sperms shall be identified and their movement shall be assess through inverted microscopes;

d) Seminiferous tubules shall be separated apart for freezing process;

dd) Freezing substances shall be dropped into separated seminiferous tubules; such seminiferous tubules shall be shaken and put in freezing vials;

e) Such vials shall be kept in ambient temperature, then the temperature shall be dropped according to the program;

g) The sample shall be put in liquid nitrogen container for storage.

Article 20. Procedures fortesticle tissue thawing

1.Testicle tissuethawing is a technique where thetesticle tissuesfrozen and stored in the storage are defrostedfor usetaking sperms.

2. Procedures:

a) The vial containing thetesticle tissueshall be taken out of the liquid nitrogen;

b) Testicle tissues shall be cleansed in washing environment;

c) Sperms shall be extracted from testicle tissue;

d) An assessment of movement of sperms shall be conducted;

dd) Thecollected spermsshall be keptand grownin the CO2incubator;

e)Sperms shall be re-assessed and used for ICSI.

Article 21. Procedures for cold storage ofeggs

1.Cold storage of eggs is a technique where eggs are retrieved from the ovary, frozen and stored in freezing environment. Retrieved and separated eggs shall be frozen through the vitrification. When the receiver is ready for pregnancy, eggs shall be thawed.

2. Procedures:

a) An assessment of quality of egg shall be made, parameter shall be fully recorded before freezing eggs. Depending on the environment, the procedures may be adjusted from the standard procedures;

b) The environment for vitrification shall be prepared;

c) Information about the patient and date of conduct shall be written on the egg container. Information shall be compared and checked;

d) Liquid nitrogen containers shall be prepared;

dd) Quality of egg shall be assessed before the freezing;

e)Technical plates containing environment of vitrification shall be prepared;

g) Eggs shall be sucked in vitrification environment;

i) Eggs shall be taken out of the vitrification environment and laid on egg container, using a pipette;

k) The egg container shall be sucked;

l) The egg container shall be stored in a liquid nitrogen container.

Article 22. Procedures foregg thawing

1.Egg thawingis a technique where eggs frozen and stored incontainers are thawed.

2. Procedures:

a) Thawing environment shall be prepared;

b) Name and number of the dossier, date of retention and name of the patient written on the cryotop shall be checked;

c) The egg container that are taken out of the liquid nitrogen shall be immediately sucked in the prepared environment plate;

d) Eggs shall be moved through prepared thawing environments;

dd) Form of the eggs shall be assessed and used for the next treatment technique.

Article 23. Procedures for cold storage ofembryo

1. The cold storage ofembryosis a technique wherean embryosample is frozen and stored in a cold storage environment. When the receiver is ready for pregnancy,the embryoshall be thawedand transferred to the uterus. Vitrification freezing brings more advantages than slow freezing; thus, currently, most of childbirth assistance center apply this measure.

2. Procedures:

a) An assessment of quality ofthe embryoshall be made, parametersshall be fully recorded before freezingthe embryo;

b) The environment for vitrification shall be prepared;

c) Embryo containers shall be prepared;

d) Liquid nitrogen containers shall be prepared;

dd)Embryoshall be sucked in vitrification environment;

e) The embryo shall be laid on embryo container and shall be sucked in liquid nitrogen;

g) Embryo containers shall be stored in the container;

h) Records shall be completed.

Article 24. Procedures forembryothawing

1.Embryo thawingis a technique whereembryosfrozen and stored in containers are thawed.

2. Procedures

a) The environment forthawingshall be prepared;

b) Nameof patient,number of the dossier, date of retention written on theembryo containershall be checked;

c) The embryo container shall be taken out of nitrogen liquid;

d)The embryoshall be moved through prepared thawing environments;

dd) The thawed embryo shall be moved to growing environment;

e) An assessment of the viability of embryos and blastomeres shall be conducted;;

g) The embryo shall be grown in the CO2incubator and shall be supervised until it is transferred.

Article 25.Frozen embryo transfer(FET)procedures

1.Frozen embryo transfer (FET) is a procedure where one or a number of frozen embryo are thawed and transferred to the uterus of the prepared receiver.

2. Procedures

a) The endometrium of the receiver shall be prepared since the beginning of the period;

b) The development of the uterine mucous membrane shall be supervised;

c) When all conditions for embryo transfer is satisfied, the plan on embryo transfer and date of transfer shall be notified to the embryo growing laboratory;

d) The embryo shall be thawed; an assessment of the development of the embryo and quality of the embryo before the transfer shall be conducted;

dd) The embryo shall be transferred into the uterus;

e) The luteal phase assistance shall be conducted;

g) A determination of bhCG after embryo transfer shall be conducted;

h)A post-embryo transfer ultrasound scan shall be conducted so that the development and location of the pregnancy is determined.

Article 26.In vitro maturation procedure (IVM)

1.In vitro maturation is a technique where eggs are retrieved from the ovary from slightly-stimulated eggs that are grown in growing plates and inseminate sperms through the intra-cytoplasmic sperm injection (ICSI).

2. Procedures:

a) The quantity of the follicles and the development of the follicles and uterine mucous membrane shall be supervised since the beginning of the period. FSH and/or hCG may be added during the supervision;

b) Small follicles shall be retrieved when possible;

c) The retrieved eggs may have grown after the retrieval. Otherwise, the eggs shall be grown and their maturity shall be checked.

d) Regarding mature eggs, follicular cells shall be separated from eggs;

dd) The spermsshall be injected into the cytoplasm of the eggs;

e)The insemination of eggsand the sperms after injection shall be inspected;

g) The embryo shall be grown;

h) The embryo shall be transferred into the uterus;

i) A determination of bhCG after embryo transfer shall be conducted;

k) An ultrasound scan shall be conducted so that the developmentof the embryo, the quantity andlocation of the pregnancy is determined.

Article 27. In vitro fertilization procedure (IVF)with borrowed eggs

1.In vitro fertilization (IVF)with borrowed eggsis a childbirth assistance technique where sperms inseminate eggsof the egg donor in an environmentoutside the body (in vitro).Collected embryo shall be transferred to the uterus of the receiver whose uterus mucous membrane has been prepared.

2.Procedures

a) Fresh embryos:

-The period of the egg donor and receiver shall be adjusted;

-The ovary of the egg donor shall be stimulated and the uterine mucous membrane of the receiver shall be prepared;

-The development of the follicles of the egg donor shall be supervised;

- The development of the uterine mucous membraneof the receivershall be supervised;

-When a follicle has grown to a suitable age, it shall be injected a mature stimulation drug;

- Theeggs ofthe egg donor shall beretrievedand the uterine mucous membrane of the receiver shall be prepared;

-Sperms of the husband of the egg receiver shall be retrieved, selected and washed;

-Sperms of the husband shall be enable to inseminate eggs of the donor;

-The insemination shall be inspected;

-The embryos shall be assessed and selected;

-The selected embryo shall be transfer to the uterus;

-The receiver shall be assisted with endocrine after the transfer of embryo;

-bhCG shall be assessed after the transfer of embryo;

-A post-transfer ultrasound scan shall be conducted to determine the development quantity and location of the pregnancy.

b) Unfresh embryos:

-The ovary of the egg donor shall be stimulated.

-Eggs shall be retrieved and IVF or ICSI using the sperms of the husband of the receiver shall be conducted to produce embryos. All embryos shall be grown and frozen;

-Then, the uterine mucous membrane of the receiver shall be prepared; the embryos shall be thawed and the embryo transfer shall be conducted.

Article 28. In vitro fertilization procedure (IVF) with borrowed sperms

1.In vitro fertilization procedure (IVF) with borrowed spermsis a technique where sperms of the donor are enable to inseminate eggs of the receiver. The collected embryo shall be transferred to the uterus to develop or shall be frozen for later use.

2.Procedures

a) The ovarian stimulation and egg retrieval shall be conducted on the receiver;

b) The ICSI shall be conducted using the sperm of the donor that is thawed;

c) Embryos shall be produced and transferred to the uterus of the receiver.

Article 29. Procedure for selective reduction of embryos

1. Selective reduction of embryos is a technique where a needle is used to put into the vagina (according to the ultrasound scan screen) to destroy a number of gestational sacs in case of multiple pregnancies.

2.Procedures:

a) The best time for reduction of embryos is when the pregnancy ages 7 to 8 weeks;

b) The patient shall be provide with information about reasons for embryo reduction, procedures and possible accidents of embryo reduction;

c) The patient shall be injected the analgesic for systemic anaesthesia or partial anaesthesia, or combined with pre-medicated anaesthesia;

d) The vulva and the vagina shall be cleansed;

dd) The patient shall be covered with the operation towel;

e) An ultrasound scan shall be conducted so that quantity and location of gestational sacs are re-assessed; embryos subject to be destruction shall be carefully selected;

g) The needle shall be put exactly into the embryo subject to destruction according to the guidance of the ultrasound scan screen; when the needle has been put into the correct embryo, the embryo shall be sucked.

h) The destroyed embryo shall be inspected to ensure that the fetal heart does not beat anymore;

i) If the pregnancy is big, potassium chloride shall be pumped into the heart chamber of the pregnancy;

k) Preventive antibiotics shall be taken;

l) Post-operation supervision shall be conducted;

m) The patient shall take re-examination after the selective reduction of embryos.

ChapterV

RETENTION AND SHARING OF INFORMATION

Article 30. Retention of information

1. Information about IVF cases shall be retained at medical facilities carrying out the IVF for at least 02 (two) years since the last treatment procedure finished.

2. Information about the donation and receipt of sperms, eggs, embryos and the cases of surrogacy for humanitarian reasons shall be retained at medical facilities for at least 20 (twenty) years since the last treatment procedure finished.

Article 31.Sharingof information

1.Department of Maternal Health and Children(the Ministry of Health) shall make a plan to formulate a system connecting all medical facilities qualified for carrying out in-vitro fertilization technique in Vietnam so that information and data about sperm, egg and embryo donation and surrogacy for humanitarian reasons are under management.

2. National childbirth assistance center is responsible for working as the contact point, cooperating with Department of Maternal Health and Children (the Ministry of Health) in formulating a general database about childbirth assistance for nationwide use.

3. When the database system has been formulated, medical facilities qualified for carrying out the in-vitro fertilization technique shall input sufficiently information to the general database system, ensuring the sharing of information between the Ministry of Health and qualified medical facilities; ensuring that the donation and receipt of sperms, eggs, embryos and the surrogacy for humanitarian reasons are conducted according to law.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 32. Effect

This Circulartakes effect February 15, 2016

Circular No.07/2003/TT-BYTdated March 25, 2003 by the Minister of Health and section IV. Procedures for in-vitro fertilization specified in Circular No.12/2012/TT-BYTdated July 15, 2012 by the Minister of Health are annulled by the effect of this Circular.

Article 33. Responsibilities

Director of Department of Maternal Health and Children; Director of Medical Service Administration, Heads of units affiliated to the Ministry of Health; Director of the Departments of Health of central-affiliated cities and provinces; agencies, organizations and individuals that are relevant are responsible for implementing this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministryof Health (viaDepartment of Maternal Health and Children) for consideration and solution./.

For the Minister

The Deputy Minister

Nguyen Viet Tien