This Circular provides detailed regulations on in vitro fertilization techniques and conditions for surrogacy for humanitarian purposes, applicable to healthcare facilities meeting the required conditions. The regulations include health standards of the individuals involved, infrastructure, equipment, personnel, technical procedures, information retention, and data sharing.
적용 범위
Healthcare facilities meeting the conditions stipulated in Decree No. 10/2015/NĐ-CP; relevant agencies, organizations, and individuals.
핵심 사항
- Individuals undergoing in vitro fertilization techniques must be in good health and have a conclusion from the head of the facility.
- The facility conducting the procedure must have a neonatal intensive care unit with a minimum area of 500 square meters for the procedure room, medical equipment, and trained personnel.
- The examination and diagnosis process for infertility includes clinical and paraclinical investigations for both spouses.
- Comprehensive counseling for couples before undergoing in vitro fertilization techniques, including details about the treatment process, success rates, costs, and potential complications.
- Detailed regulations are provided for techniques such as oocyte retrieval, embryo transfer, sperm and oocyte thawing.
- Information on sperm donation, egg donation, embryo donation, and surrogacy must be retained for at least two years and shared through a network connecting facilities.
🌐 이 문서의 사회적 영향
- Facilitate favorable conditions for those seeking in vitro fertilization techniques to increase success rates.
- Ensure strict management of sperm donation, egg donation, embryo donation, and surrogacy to guarantee safety and transparency.
- Increase costs for those undergoing the technique due to requirements for medical equipment and highly qualified personnel.
- May create psychological burdens for patients who must go through complex regulations and procedures.
❓ 자주 묻는 질문
What criteria must individuals undergoing in vitro fertilization techniques meet?
Individuals undergoing in vitro fertilization techniques must not suffer from illnesses that render them unfit for the procedure, must not be infected with sexually transmitted diseases, HIV, or genetic disorders affecting the life and development of the child. They also need a written conclusion from the head of the facility.
What infrastructure requirements must facilities conducting in vitro fertilization techniques meet?
Infrastructure must include a neonatal intensive care unit with a minimum area of 500 square meters for the procedure room, medical equipment such as CO2 incubators, warming cabinets, sperm storage tanks, ultrasound machines, inverted microscopes, and trained personnel.
What does the infertility diagnosis process include?
The infertility diagnosis process includes clinical investigations for both spouses, ovarian reserve assessment, hormone testing, fallopian tube patency and function testing, blood cell count, biochemical blood tests, hepatitis B, syphilis, tuberculosis, HIV, Chlamydia screening, cervical cancer screening via HPV, vaginal smear tests.
What contents are included in pre-procedure counseling for in vitro fertilization techniques?
Counseling includes explaining the treatment process, expected timing for oocyte retrieval and sperm collection, embryo transfer, possibility of freezing all embryos when there is a risk of ovarian hyperstimulation syndrome or unfavorable endometrial conditions, success rates of in vitro fertilization, potential complications, and treatment costs.
How long must information on sperm donation, egg donation, embryo donation, and surrogacy be retained?
Information on sperm donation, egg donation, embryo donation, and surrogacy must be retained for at least twenty years from the date of the last treatment cycle.
전문
CIRCULAR
DETAILING CERTAIN PROVISIONS OF DECREE NO. 10/2015/NĐ-CP DATED JANUARY 28, 2015 OF THE GOVERNMENT ON CONCEPTION THROUGH IN-VITRO FERTILIZATION TECHNIQUESAND CONDITIONS FOR SURROGATE PREGNANCIES FOR HUMANITARIAN PURPOSES
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BASED ON DECREE NO. 63/2012/NĐ-CP DATED AUGUST 31, 2012 OF THE GOVERNMENT ON FUNCTIONS, TASKS, POWERS, AND ORGANIZATIONAL STRUCTURE3.2. Email: DECREE NO. 10/2015/NĐ-CP DATED JANUARY 28, 2015 OF THE GOVERNMENT ON CONCEPTION THROUGH IN-VITRO FERTILIZATION TECHNIQUES, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP transmission within the scope of payment of the health insurance fund.
Pursuant to DecreeNo. AND CONDITIONS FOR SURROGATE PREGNANCIES FOR HUMANITARIAN PURPOSES;ịnh THE MINISTER OF HEALTH ISSUES THIS CIRCULAR TO DETAIL CERTAIN PROVISIONS OF DECREE NO. 10/2015/NĐ-CP DATED JANUARY 28, 2015 OF THE GOVERNMENT ON CONCEPTION THROUGH IN-VITRO FERTILIZATION TECHNIQUES Vial AND CONDITIONS FOR SURROGATE PREGNANCIES FOR HUMANITARIAN PURPOSES.ì THIS CIRCULAR REGULATES HEALTH STANDARDS FOR PERSONS UNDERGOING IN-VITRO FERTILIZATION TECHNIQUES, PREGNANCY, AND BIRTH; INFRASTRUCTURE, EQUIPMENT, AND STAFF OF MEDICAL ESTABLISHMENTS PERMITTED TO PERFORM IN-VITRO FERTILIZATION TECHNIQUES; PROCEDURES FOR EXAMINATION AND DIAGNOSIS OF INFERTILITY; PROCEDURES FOR IN-VITRO FERTILIZATION TECHNIQUES; INFORMATION STORAGE AND SHARING.
Appendix 02 attached to this Circular.
THIS CIRCULAR APPLIES TO MEDICAL ESTABLISHMENTS MEETING THE REQUIREMENTS SET OUT IN DECREE NO. 10/2015/NĐ-CP DATED JANUARY 28, 2015 OF THE GOVERNMENT ON CONCEPTION THROUGH IN-VITRO FERTILIZATION TECHNIQUES AND CONDITIONS FOR SURROGATE PREGNANCIES FOR HUMANITARIAN PURPOSES (HEREINAFTER REFERRED TO AS DECREE NO. 10/2015/NĐ-CP); RELEVANT AUTHORITIES, ORGANIZATIONS, AND INDIVIDUALS.on REGULATIONS ON HEALTH STANDARDS FOR PERSONS UNDERGOING IN-VITRO FERTILIZATION TECHNIQUES; INFRASTRUCTURE, EQUIPMENT, AND STAFF OF ESTABLISHMENTS PERFORMING IN-VITRO FERTILIZATION TECHNIQUESARTICLE 3. HEALTH STANDARDS FOR PERSONS UNDERGOING IN-VITRO FERTILIZATION TECHNIQUES 1. NOT SUFFERING FROM ILLNESSES THAT MAKE THEM INCAPABLE OF UNDERGOING IN-VITRO FERTILIZATION TECHNIQUES, PREGNANCY, AND BIRTH; NOT SUFFERING FROM SEXUALLY TRANSMITTED DISEASES, HIV, GROUP A AND B INFECTIOUS DISEASES; NOT SUFFERING FROM GENETIC DISEASES THAT AFFECT THE LIFE AND DEVELOPMENT OF THE CHILD AT BIRTH; NOT SUFFERING FROM MENTAL ILLNESSES OR OTHER DISEASES THAT PREVENT THEM FROM UNDERSTANDING AND CONTROLLING THEIR BEHAVIOR.inh Industry and Vial 2. PERSONS UNDERGOING IN-VITRO FERTILIZATION TECHNIQUES MUST HAVE A WRITTEN CONCLUSION BY THE HEAD OF THE ESTABLISHMENT PERMITTED TO PERFORM IN-VITRO FERTILIZATION TECHNIQUES CONFIRMING THAT THEY ARE FIT TO UNDERGO IN-VITRO FERTILIZATION TECHNIQUES, PREGNANCY, AND BIRTH.onARTICLE 4. INFRASTRUCTURE REQUIREMENTS FOR ESTABLISHMENTS PERFORMING IN-VITRO FERTILIZATION TECHNIQUES
GENERAL PROVISIONS
Article 1. Scope of Regulation
1. MUST HAVE A UNIT FOR CARE OF PREMATURE NEWBORNS, EMERGENCY RESUSCITATION, AND ENDOCRINOLOGY TESTING WITH CAPACITY TO PROVIDE RESULTS ON THE SAME DAY.
Article 2. Applicability
2. MUST HAVE A SEPARATE UNIT FOR IN-VITRO FERTILIZATION TECHNIQUES WITH AN AREA OF AT LEAST 500 SQM (INCLUDING PATHWAYS) AND THE FOLLOWING ROOMS:
a) PATIENT RECEPTION;
b) MALE AND FEMALE CLINICAL EXAMINATION;
c) OVUM ASPIRATION;
d) SPERM COLLECTION;
đ) CULTURE LAB;
e) ULTRASOUND;
g) SPERM ANALYSIS AND WASHING LAB MEETING WORLD HEALTH ORGANIZATION RECOMMENDATIONS.
ARTICLE 5. MEDICAL EQUIPMENT REQUIREMENTS FOR ESTABLISHMENTS PERFORMING IN-VITRO FERTILIZATION TECHNIQUES
MUST HAVE THE FOLLOWING MINIMUM MEDICAL EQUIPMENT:
c) Ovum aspiration;
d) Sperm retrieval;
đ) In vitro culture laboratory;
e) Ultrasound;
g) Semen testing and washing to meet the standards recommended by the World Health Organization;
Article 5. Medical equipment requirements for facilities performing in vitro fertilization techniques
Must have the following minimum medical equipment:
Article 6. Staffing regulations for facilities conducting in vitro fertilization techniques
Individuals directly performing in vitro fertilization techniques must meet the following requirements:
1. Hold a degree, certificate, or recognition of training in in vitro fertilization techniques (certifications and certificates of personnel trained in in vitro fertilization techniques abroad at institutions meeting standards equivalent to those in Vietnam shall be recognized).
2. Have confirmation of having directly performed at least twenty (20) cycles of infertility treatment using in vitro fertilization techniques.
3. Possess a practice license in accordance with the Law on Medical Examination and Treatment.
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1. CO2 incubator |
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2. Incubator |
03 units |
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3. Sperm storage container |
01 piece |
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4. Centrifuge machine |
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5. Refrigerator |
01 piece |
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6. Drying cabinet |
01 piece |
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7. Frozen embryo storage container |
01 piece |
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8. Ultrasound machine with vaginal probe |
02 pieces |
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9. Inverted microscope |
01 piece |
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10. Phase contrast microscope |
02 pieces |
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11. Workbench set |
02 sets |
Chapter III
PROCEDURE FOR INFERTILITY EXAMINATION AND DIAGNOSIS
Article 7. Infertility examination and testing for couples
1. Requirements: Conduct medical history inquiry and physical examination for both husband and wife.
2. For the wife
a) Clinical examination:
- Internal medicine and surgery examination;
- Gynecological and breast examination.
b) Ancillary clinical tests:
- Ovarian reserve assessment through follicle count or AMH test;
- Ovarian function evaluation through hormone tests when necessary;
- Fallopian tube patency and function check;
- Blood cell count and blood biochemistry tests;
- Hepatitis B, syphilis, tuberculosis, HIV (note pre- and post-HIV testing counseling according to laws on HIV/AIDS prevention and control), Chlamydia tests;
- Cervical cancer screening through HPV and vaginal smear tests;
- Other special tests (depending on the patient): Cytomegalovirus, Anti-phospholipid antibodies, mammography, genetic testing.
3. For the husband
a) Semen analysis according to World Health Organization guidelines;
b) Tests:
- Hepatitis B, syphilis, tuberculosis, HIV (note pre- and post-HIV testing counseling according to laws on HIV/AIDS prevention and control);
c) When necessary or if there are suspicions of accompanying abnormalities:
- Internal medicine examination;
- Genital examination;
- Additional tests as needed.
Article 8. Infertility examination and testing for single women
Single women shall undergo examination and testing as stipulated in Clause 2 of Article 7 of this Circular.
Chapter IV
PROCEDURE FOR IN VITRO FERTILIZATION TECHNIQUES
Article 9. Counseling for couples undergoing in vitro fertilization
1. Explain the treatment process including clinical and ancillary clinical examinations, tests, ovarian stimulation protocols, medication duration, and monitoring during medication use.
2. Expected time for egg retrieval and sperm collection.
3. Expected time for embryo transfer and possibility of freezing all embryos due to risk of ovarian hyperstimulation syndrome or unfavorable endometrial conditions.
4. Support for progesterone supplementation and follow-up after embryo transfer.
5. Success rate of in vitro fertilization method.
6. Potential complications.
7. Treatment costs.
Article 10. Counseling for special cases
1. Counseling for oocyte donation in vitro fertilization
a) Oocyte donation in vitro fertilization cases include older women, premature ovarian failure, poor ovarian response, and genetic abnormalities;
b) In addition to the information required to be provided to couples as specified in Article 9 of this Circular, additional counseling should include:
- Written consent from both donor and recipient spouses;
- Ovarian stimulation and monitoring procedures for the oocyte donor;
- The recipient may prepare the uterine lining with medication simultaneously with the donor's ovarian stimulation to allow fresh embryo transfer or freeze all embryos created from the donor's oocytes and the husband's sperm for subsequent transfer;
- Success rates depend on the donor's age and receptivity of the recipient's uterus;
- Genetic characteristics of the child born;
- Complications of oocyte retrieval for the donor.
2. Counseling for in vitro fertilization due to male partner's lack of sperm
a) The male partner will undergo testicular biopsy or epididymal aspiration to determine the presence of sperm, if present, in vitro fertilization can proceed using the male's sperm;
b) Explain the process of sperm retrieval through surgical methods (testicular biopsy or epididymal aspiration) and in vitro fertilization using intracytoplasmic sperm injection (ICSI);
c) Provide counseling on success rates and costs;
d) Provide counseling on potential complications;
đ) If sperm cannot be retrieved, donor sperm may need to be used;
e) Genetic characteristics of the child born if donor sperm is used.
3. Counseling for embryo donation in vitro fertilization: counseling content follows the provisions of Clause 1 of this Article.
4. Counseling for single women undergoing in vitro fertilization with donated sperm
In addition to the information required to be provided as stipulated in Article 9 of this Circular, additional counseling should include the genetic characteristics of the child born.
Article 11. In Vitro Fertilization (IVF) Process
1. Overview: In vitro fertilization (IVF) is a reproductive assistance technique where sperm fertilizes an egg in an external body environment (in vitro). The resulting embryo will be transferred to the uterus for implantation or frozen for later use.
2. Procedure:
a) Examine the couple and conduct necessary basic tests;
b) Evaluate ovarian reserve;
c) Stimulate the ovaries;
d) Monitor follicle development;
đ) Inject medication to mature follicles when conditions are appropriate;
e) Retrieve eggs through the vagina under ultrasound guidance;
g) Begin progesterone support if fresh embryo transfer is performed;
h) Simultaneously collect the husband's sperm and prepare it;
i) Allow sperm to fertilize the egg using classical in vitro fertilization (IVF) method or intracytoplasmic sperm injection (ICSI);
k) Culture in a CO2 incubator;
l) Check egg fertilization;
m) Embryo culture and monitoring;
n) Embryo transfer: may occur on day 2, day 3, or day 5 (blastocyst), depending on the protocol of each IVF facility;
o) Continue progesterone support if fresh embryo transfer is performed;
p) Test pregnancy with serum beta-hCG quantification;
q) Perform vaginal ultrasound to confirm fetal development and position.
Article 12. Sperm Preparation Procedure for In Vitro Fertilization
1. Overview: Sperm preparation aims to remove dead sperm and seminal plasma to obtain a sample of healthy sperm for in vitro fertilization.
2. Procedure
a) Collect semen sample:
- The husband abstains from sexual intercourse for 3 to 7 days before collecting the semen sample;
- Prepare the equipment used to process the sperm sample, with each person having their own set of equipment labeled with the wife's and husband's names or coded;
- Collect semen by masturbation. Wash hands and genital area thoroughly before collection.
b) Prepare sperm:
- Allow the semen sample to fully liquefy in a warm cabinet, record the time of full liquefaction;
- Take a small amount of semen to evaluate general indicators;
- Prepare sperm using basic techniques; - The sperm-containing sediment obtained after preparation will be used for IVF or ICSI.
Article 13. Oocyte Retrieval Procedure for In Vitro Fertilization
1. Overview: Oocyte retrieval is a technique where the oocyte is removed through the vagina under ultrasound guidance and then fertilized with sperm in an external body environment.
2. Procedure:
a) Pain relief by general anesthesia or local anesthesia, possibly combined with pre-anesthesia;
b) Fast before oocyte retrieval, urinate completely before the procedure;
c) Clean the vulva, vagina, and cervix with physiological saline;
d) Cover the feet and abdomen with a sterile drape;
đ) Rinse the syringe and oocyte aspiration needle with the aspiration medium before aspiration;
g) Proceed with oocyte aspiration under ultrasound guidance;
h) Immediately transfer the aspirated follicular fluid to the laboratory for finding and retrieving the oocyte;
i) Rinse the syringe and needle again to avoid leaving the oocyte in the needle and syringe.
3. Post-retrieval Monitoring
a) Rest in the post-retrieval room;
b) Monitor pulse, blood pressure, breathing rate, abdominal pain, vaginal bleeding;
c) Guide medication use, schedule embryo transfer date if fresh embryo transfer is performed.
Article 14. Embryo Transfer Procedure
1. Overview: embryo transfer is a technique in which one or more embryos are transferred into the uterus of the recipient for implantation.
2. Procedure:
a) Prepare the embryos for transfer on a dish, carefully check the number of embryos, name, age, and file number;
b) Need to refrain from urination to ensure bladder distension;
c) Assume the gynecological position;
d) Cleanse the vaginal area;
đ) Open the speculum, clean the cervix with the transfer medium;
e) Gently insert the outer catheter through the cervical canal up to the uterine fundus while observing under abdominal ultrasound;
g) Prepare to aspirate the embryos into the inner catheter after successfully inserting the outer catheter through the cervical canal;
h) Gently insert the inner catheter containing the embryos into the uterine cavity, with the catheter tip about 2 cm away from the uterine fundus;
i) Gently inject the embryos into the uterine cavity;
k) Gently remove the catheter from the uterine cavity;
l) Check the catheter for cleanliness and any remaining embryos;
m) Remove the speculum;
n) Rest for at least 30 minutes before leaving;
o) Support progesterone therapy.
Article 15. Intracytoplasmic Sperm Injection (ICSI) Procedure
1. Overview: intracytoplasmic sperm injection is a micro-manipulation technique that directly injects a single sperm into the cytoplasm of an egg to achieve fertilization.
2. Procedure:
a) Prepare the sperm sample for ICSI;
b) The egg, after aspiration, is incubated in a warming chamber prior to performing the technique;
c) Prepare the ICSI dish;
d) Adjust the microscope and micro-manipulation equipment;
đ) Proceed to separate the polar body from the egg;
e) Proceed to inject the sperm into the egg's cytoplasm;
g) Incubate the injected egg in a CO2 culture incubator;
h) Check for fertilization.
Article 16. Sperm Retrieval Procedure
1. Overview: sperm retrieval is a technique of aspirating sperm from the epididymis or testicular biopsy to be used for fertilization with eggs using intracytoplasmic sperm injection for cases without sperm in the semen or inability to ejaculate.
2. Procedure:
a) Administer general anesthesia or local anesthesia;
b) Clean the genital organs and surrounding areas with physiological saline;
c) Fix the epididymis (if aspirating from the epididymis) or fix the testicle;
d) Aspirate the epididymis or testicle or perform a testicular biopsy;
e) Search for sperm in the aspirated sample or biopsy tissue;
g) Prepare the sperm from the sample or separate sperm from the testicular tissue;
h) Provide post-procedure care instructions.
Article 17. Sperm Cryopreservation Procedure
1. Overview: sperm cryopreservation is a technique where a sperm sample is frozen and stored in a cold preservation environment. When needed, it can be thawed for use.
2. Slow Freezing Procedure:
a) Evaluate sperm quality before cryopreservation according to World Health Organization standards;
b) Mix the sperm with cryoprotectant;
c) Package, label with patient name, code, and cryopreservation date;
d) Lower the temperature of the sample;
đ) Store in liquid nitrogen.
Article 18. Sperm Thawing Procedure
1. Overview: sperm thawing is a technique where a frozen sperm sample stored in a preservation container is thawed, then filtered and washed for use.
2. Procedure:
a) Remove the storage tube containing the sperm from liquid nitrogen;
b) Place the storage tube in warm water at 37°C;
c) Open the container and collect the thawed sperm;
d) Evaluate sperm quality after thawing;
đ) Prepare the thawed sperm sample for use.
Article 19. Cryopreservation Process for Testicular Tissue
1. Overview: Cryopreservation of testicular tissue involves biopsy, identification of sperm, freezing, and storage in a cold preservation environment. When necessary, the frozen tissue can be thawed to extract sperm for use.
2. Procedure:
a) Conduct examination, testing, and counseling for the patient similar to cases involving sperm retrieval procedures.
b) Perform testicular tissue biopsy, place the tissue in a dish containing medium for cleaning.
c) Cut the testicular tissue into small pieces using specialized forceps, determine the presence of sperm, and evaluate motility under an inverted microscope.
d) Separate each seminiferous tubule for cryopreservation.
đ) Add and mix cryoprotectant solution evenly into the separated seminiferous tubules, shake well, and place in cryovials.
e) Place the vials at room temperature, then gradually decrease the temperature according to the program.
g) Transfer the samples into liquid nitrogen containers for storage.
Article 20. Thawing Process for Testicular Tissue
1. Overview: Thawing of cryopreserved testicular tissue involves retrieving the frozen tissue from storage containers to extract sperm.
2. Procedure:
a) Remove the cryovials containing testicular tissue from the liquid nitrogen container.
b) Wash the testicular tissue with washing medium.
c) Separate sperm from the testicular tissue.
d) Evaluate sperm motility.
đ) Culture sperm in a CO2 incubator.
e) Re-evaluate sperm motility and use for ICSI.
Article 21. Cryopreservation Process for Oocytes
1. Overview: Cryopreservation of oocytes involves extracting oocytes from the ovaries, freezing them, and storing them in a cold preservation environment. Oocytes should be vitrified immediately after aspiration and separation of polar bodies. When the woman is ready to conceive, the oocytes will be thawed.
2. Procedure:
a) Assess oocyte quality and record all parameters before proceeding with cryopreservation. Specific steps may vary depending on the type of medium used.
b) Prepare vitrification medium.
c) Record patient information and date of procedure on the oocyte storage device. Verify the information.
d) Liquid nitrogen storage container.
đ) Assess oocyte quality prior to vitrification.
e) Prepare technical dishes containing vitrification medium.
g) Sequentially immerse oocytes in vitrification media.
i) Use a pipette to transfer oocytes onto the storage device.
k) Immerse the storage device.
l) Store in a liquid nitrogen container.
Article 22. Thawing Process for Oocytes
1. Overview: Thawing of cryopreserved oocytes involves retrieving the frozen oocytes from storage containers to thaw them.
2. Procedure:
a) Prepare thawing medium.
b) Check name, file number, storage date, and patient name recorded on the storage tube.
c) Immediately immerse the oocyte storage device removed from liquid nitrogen into the prepared medium dish.
d) Sequentially transfer oocytes through the prepared thawing media.
đ) Evaluate oocyte morphology and use for subsequent treatment techniques.
Article 23. Cryopreservation Process for Embryos
1. Overview: Cryopreservation of embryos involves freezing and storing embryos in a cold preservation environment. When the woman is ready to conceive, the embryos will be thawed and transferred to the uterus. Vitrification offers more advantages than slow freezing and is currently widely adopted by most assisted reproductive centers.
2. Procedure:
a) Assess embryo quality and record all parameters before proceeding with cryopreservation.
b) Prepare vitrification medium in appropriate dishes.
c) Prepare embryo storage devices.
d) Prepare liquid nitrogen storage container.
đ) Sequentially immerse embryos in vitrification media.
e) Place embryos on the storage device and immerse in liquid nitrogen.
g) Store the storage device in the container.
h) Complete the storage data record.
Article 24. Embryo Thawing Procedure
1. Overview: Embryo thawing is a technique in which an embryo that has been frozen and stored in a storage container is taken out for thawing.
2. Procedure
a) Prepare embryo thawing media in appropriate dishes;
b) Check the patient's name, file number, and storage date recorded on the embryo container;
c) Remove the embryo container from nitrogen;
d) Gradually transfer the embryo through various thawing media;
đ) Transfer the thawed embryo into culture medium;
e) Evaluate the viability and death rate of embryos and blastomeres;
g) Culture the embryo in a CO2 incubator until the time of embryo transfer.
Article 25. Frozen Embryo Transfer (FET) Procedure
1. Overview: Frozen embryo transfer is a technique in which one or more thawed frozen embryos are transferred into the prepared endometrium of the recipient uterus.
2. Procedure
a) Prepare the recipient's endometrium from the beginning of the menstrual cycle;
b) Monitor the development of the endometrium;
c) When conditions are suitable for embryo transfer, notify the embryo culture room of the plan and transfer date;
d) Thaw the embryo and evaluate its development and quality before transfer;
đ) Transfer the embryo into the uterus;
e) Support the corpus luteum;
g) Measure bhCG after embryo transfer;
h) Perform ultrasound after embryo transfer to confirm fetal development and location.
Article 26. In Vitro Maturation (IVM) Procedure for Immature Oocytes
1. Overview: In vitro maturation in assisted reproduction is a technique in which immature oocytes are retrieved from small follicles in the ovaries and then cultured to maturity in culture dishes and fertilized with sperm using intracytoplasmic sperm injection (ICSI).
2. Procedure:
a) Monitor the number of follicles, their development, and the endometrium from the start of the cycle. FSH and hCG may be supplemented during monitoring;
b) Aspirate small follicles when conditions are appropriate;
c) Aspirated oocytes may already be mature at the time of aspiration. If they are not mature, continue culturing and recheck maturity;
d) Separate cumulus cells from mature oocytes;
đ) Inject sperm into the oocyte cytoplasm;
e) Check oocyte fertilization after sperm injection;
g) Culture the embryo;
h) Transfer the embryo into the uterus;
i) Measure bhCG after embryo transfer;
k) Perform ultrasound to confirm embryo development, number, and location of gestational sacs.
Article 27. Oocyte Donation In Vitro Fertilization (IVF) Procedure
1. Overview: Oocyte donation in vitro fertilization is a technique in which sperm is fertilized with donated oocytes outside the body. The resulting embryos are transferred into the prepared endometrium of the recipient uterus for implantation.
2. Procedure
a) If fresh embryo transfer is performed:
- Adjust the menstrual cycles between the donor and recipient;
- Stimulate the donor's ovaries while preparing the recipient's endometrium;
- Monitor the development of the donor's follicles;
- Monitor the development of the recipient's endometrium;
- When follicles have developed sufficiently, administer medication to trigger ovulation;
- Aspirate the donor's oocytes while preparing the recipient's endometrium for embryo transfer;
- Collect and wash the husband's sperm;
- Fertilize the donor's oocytes with the husband's sperm;
- Check fertilization;
- Evaluate and select embryos;
- Transfer the embryos into the uterus;
- Provide hormonal support to the recipient after embryo transfer;
- Measure bhCG after embryo transfer;
- Perform ultrasound after embryo transfer to confirm fetal development, number, and location.
b) If fresh embryo transfer is not performed:
- Stimulate the donor's ovaries;
- Aspirate oocytes and perform IVF or ICSI with the recipient's husband's sperm to create embryos. Culture and freeze all embryos;
- Subsequently, prepare the recipient's endometrium and transfer thawed embryos.
Article 28. In Vitro Fertilization Using Donor Sperm
1. Overview: In vitro fertilization using donor sperm is a technique where the sperm of the donor is fertilized with the egg of the recipient. The resulting embryo will be transferred to the recipient's uterus for implantation or frozen for future use.
2. Procedure
a) Stimulate the ovaries and retrieve the recipient's eggs;
b) Perform Intracytoplasmic Sperm Injection (ICSI) with thawed donor sperm;
c) Create embryos and transfer them to the recipient's uterus.
Article 29. Embryo Reduction Procedure
1. Overview: Embryo reduction is a procedure that uses ultrasound-guided needle aspiration through the vagina to reduce the number of gestational sacs in cases of multiple pregnancies.
2. Procedure:
a) The optimal time for embryo reduction is at 7-8 weeks of pregnancy;
b) Advise on the reasons for embryo reduction, the procedure, and potential complications;
c) Administer general anesthesia or local anesthesia, possibly combined with premedication;
d) Clean the external genitalia and vagina;
đ) Lay out sterile drapes;
e) Ultrasound reassessment of the number and location of gestational sacs and selection of embryos for reduction;
g) Insert the needle precisely under ultrasound guidance into the position of the embryo to be reduced, aspirate the embryo once the needle tip contacts it;
h) Check to ensure fetal heartbeat has ceased;
i) For larger fetuses, potassium chloride may be injected into the fetal heart;
k) Prophylactic antibiotics;
l) Post-procedure monitoring;
m) Follow-up examination after embryo reduction.
INFORMATION STORAGE AND SHARING
Article 30. Information Storage
1. Facilities performing in vitro fertilization techniques must organize the storage of information about in vitro fertilization cases at their facility for at least two years from the end of the last treatment cycle.
2. Facilities performing in vitro fertilization must also organize the storage of information and data regarding donors and recipients of sperm, eggs, embryos, and surrogacy for humanitarian purposes for at least twenty years from the end of the last treatment cycle.
Article 31. Information Sharing
1. The Department of Maternal and Child Health, Ministry of Health shall develop a specific roadmap to implement a network connecting all permitted healthcare facilities nationwide to manage information and data of sperm, egg, embryo donors, and surrogates for humanitarian purposes.
2. The National Infertility Treatment Center is responsible for coordinating with the Department of Maternal and Child Health, Ministry of Health to build a unified database system for infertility support, to be used nationwide.
3. After the network for data connection is established, facilities performing in vitro fertilization techniques must enter complete information into the unified database system, ensuring information sharing mechanisms between the Ministry of Health and qualified facilities for in vitro fertilization techniques; ensuring that sperm, egg, embryo donation, and surrogacy for humanitarian purposes are carried out in accordance with the law.
IMPLEMENTING PROVISIONS
Article 32. Effectiveness
This Circular takes effect from February 15, 2016
Article 33. Responsibility for Implementation
The Director of the Department of Maternal and Child Health; the Director of the Department of Medical Examination and Treatment; the Heads of units under and affiliated with the Ministry of Health; the Directors of Provincial Health Departments; relevant agencies, organizations, and individuals are responsible for implementing this Circular.
Circular No. 07/2003/TT-BYT dated March 25, 2003, guiding the implementation of Decree No. 12/2003/NĐ-CP dated February 12, 2003, of the Government on scientific childbirth methods and Section IV. In vitro fertilization procedures stipulated in Circular No. 12/2012/TT-BYT dated July 15, 2012, of the Minister of Health on in vitro fertilization and artificial insemination techniques become invalid from the date this Circular takes effect.
During implementation, if there are difficulties or obstacles, please send feedback in writing to the Ministry of Health (Department of Maternal and Child Health) for consideration and resolution./.
DEPUTY MINISTER
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