Medical institutions engaged in assisted human reproduction technology (hereinafter referred to as medical institutions) shall comply with these norms.
I. Technical specifications for artificial insemination
Artificial insemination is divided into artificial insemination by Husband Semen (AIH) and artificial insemination by Donor Semen (AID) according to the source of sperm. AID). According to the site of insemination, they are divided into Intravaginal Insemination (IVI), Intracervical Insemination (ICI), Intrauterine Insemination (IUI) and Intratubal Insemination (IUI). Artificial Insemination (Intratubal Insemination, ITI), among others.
(I) Basic Requirements
1. Conditions for Institutional Setup
(1) It must be a general hospital or a specialized hospital with a license to practice medicine;
(2) The implementation of artificial insemination with donor sperm must obtain a certificate of approval from the Ministry of Health, and the implementation of artificial insemination with the husband's semen must obtain a certificate of approval from the health administrative department of the province, autonomous region, or municipality directly under the central government;
(3) To carry out artificial insemination by donor sperm, there must be a sperm supply agreement with a human sperm bank that has obtained a Certificate of Approval of Human Sperm Bank;
(4) There are other conditions required by law or by the competent authorities.
2. Personnel Requirements
(1) A minimum of two physicians, two laboratory staff and one nurse specializing in reproductive medicine, all of whom have good professional ethics.
(2) The practitioners must be qualified as licensed physicians, with clinical obstetrics and gynecology and reproductive endocrinology theory and practical experience, and experience in gynecological ultrasound. The person in charge must have the title of associate high school and above medical specialty and technology. Laboratory staff has the ability of semen analysis and sperm processing. Nurses are qualified as licensed practical nurses.
3. Place RequirementsThe place contains waiting room, consultation and examination room, ultrasound room, artificial insemination laboratory, insemination room and other auxiliary areas. The total area shall not be less than 100 M2, of which the artificial insemination laboratory and insemination room dedicated area of not less than 20 M2. In addition, the medical institution shall have gynecological endocrine determination, imaging, genetics and other related examination conditions.
4, equipment conditions
(1) more than 2 gynecological examination beds;
(2) 1 ultrasound machine (configured with a vaginal probe);
(3) 1 biomicroscope;
(4) 1 small centrifuge;
(5) 100 ultra-clean bench;
(6) carbon dioxide thermostat;
(7) 2-3 liquid nitrogen tanks;
(8) refrigerator.
The above equipment is required to be in good working condition and qualified by professional inspection.
(2) Management
1, before the implementation of insemination, infertile couples must sign the Informed Consent.
2. Sperm supply for artificial insemination can only be obtained from sperm banks with approved certificates.
3. Medical institutions must keep real-time medical records and follow-up visits, and the subject of donor insemination should give feedback to the sperm bank on pregnancy and offspring. Records should be kept permanently.
4. In addition to the official letter issued by the judicial authorities and the consent of the parties concerned, the insemination medical institution shall conceal the identity information and detailed address of the recipient couple when any other accessor inspects the records. Non-relevant persons shall be denied access to the records.
5. Artificial insemination must have perfect and sound rules and regulations and technical operation manuals.
6. Self-examination of artificial insemination must be carried out on a regular basis, and clinical and technical information must be provided to the health authorities.
(3) Indications and contraindications
1. Indications
(1) Artificial insemination of husband's semen:
1) Male infertility due to oligozoospermia, weak spermatozoa, liquefaction abnormality, sexual dysfunction, genital deformities and so on.
②Female infertility due to abnormal cervical mucus secretion, reproductive tract deformities and psychological factors leading to inability to have sexual intercourse.
③Immune sterility.
④Unexplained infertility.
(2) Artificial insemination with donor sperm
①Azoospermia, severe oligozoospermia, hypospermia and dyszoospermia.
②The person who expects to have children after vasectomy and fails the reversal operation and ejaculation disorder.
3) The male partner and/or family has serious hereditary diseases that are not suitable for fertility.
④Mother and child blood group incompatibility cannot get a surviving newborn.
5 Unexplained infertility.
2. Contraindications
(1) Obstacles to the combination of sperm and egg caused by tubal factors in the female partner.
(2) The woman suffers from acute infection of the genitourinary system or sexually transmitted diseases.
(3) The woman suffers from genetic diseases, serious physical diseases, and psychosomatic disorders.
(4) There is a history of birth of babies with congenital defects and it is confirmed that it is due to female factors.
(5) The woman is exposed to teratogenic amounts of radiation, poisons, drugs and is in the period of action.
(6) The woman is addicted to alcohol or drugs.
(D) Technical procedures and quality control
1. Technical procedures
(1) Selection of indications and exclusion of contraindications.
(2) Artificial insemination can be performed under natural cycle or drug ovulation promotion cycle, but the application of ovulation promotion drugs for the purpose of multiple pregnancy is prohibited.
(3) The growth and development of follicles is monitored by ultrasound or relevant hormone levels.
(4) Timing of ovulation during natural menstruation or drug-induced ovulation cycles, and artificial insemination at the appropriate time.
(5) Artificial insemination can be performed by intravaginal insemination (IVI), intracervical insemination (ICI), intrauterine insemination (IUI), and intrafallopian insemination (ITI). Intrauterine insemination (IUI) and intrafallopian insemination (ITI) sperm must be washed and processed before being injected into the uterine cavity.
Fresh semen can be used for husband semen insemination, while frozen semen must be used for donor insemination.
(6) Drugs can be used to support luteal function after artificial insemination.
(7) Biochemical pregnancy is established 14-16 days after IUI, and clinical pregnancy is confirmed by ultrasound after 5 weeks.
2. Quality standards
(1) The number of forward-moving spermatozoa injected into the husband's semen for artificial insemination is more than 1 million.
(2) Frozen spermatozoa used for donor insemination must have a mobility rate of more than 35% after resuscitation.
(3) The clinical pregnancy rate per cycle must not be less than 10%.
II. Specification of In Vitro Fertilization/Embryo Transfer (IVF/ET) and its Derivative Techniques IVF/ET and its Derivative Techniques currently include In Vitro Fertilization/Embryo Transfer (IVF/ET), Gamete/Combined Gamete Intra-Tubal Transplantation (GTT) or Intra-Uterine Transplantation (IUT), Intracytoplasmic Sperm Injection (ICSI), Pre-implantation Genetic Diagnosis (PGD), and Pre-implantation Genetic Diagnosis (PGD). Preimplantation Genetic Diagnosis (PGD), Egg Gifting, Embryo Gifting, and more.
(I) Basic Requirements
1. Conditions for Institutional Setup
(1) It consists of two parts: the Clinical (hereinafter referred to as the Clinical) of Reproductive Specialties and the Laboratory of In Vitro Fertilization (hereinafter referred to as the Laboratory).
(2) If a sperm bank is built at the same time, it must be managed separately.
(3) There is a general director, a clinical director and a laboratory director.
(4) There must be no fewer than six staff on staff specialized in reproduction, including no fewer than four clinical and laboratory professionals and no fewer than two nursing staff.
(5) The medical and technical personnel on staff of the institution shall receive professional and technical training.
(6) The institution's on-staff technicians shall not be doubled up by persons outside the organization.
(7) A person may only have a staff member on staff at one institution.
(8) Foreign physicians coming to China or physicians from China's Taiwan, Hong Kong and Macao Special Administrative Regions coming to the Mainland to engage in human assisted reproduction diagnostic and treatment activities shall be in accordance with the relevant regulations on the management of foreign physicians practicing medicine in China or physicians from China's Taiwan, Hong Kong and Macao Special Administrative Regions practicing medicine in the Mainland.
2. Requirements for staff on board
(1) Doctors
1) Clinical doctors must have a bachelor's degree or above in medicine, and at least one of them must have a senior professional and technical title in medicine.
Persons engaged in reproductive specialties must be practicing physicians of obstetrics and gynecology or urology with intermediate or higher professional and technical titles.
② Clinical director shall be engaged in the reproductive specialty with senior technical title of licensed physicians.
3 at least one doctor with the following knowledge and working ability: mastery of female reproductive endocrinology clinical expertise, especially the use of ovulation drugs and hormonal control of the menstrual cycle.
Mastery of gynecological ultrasound technology and technical competence in follicular ultrasound monitoring and ultrasound-mediated vaginal puncture for egg retrieval.
Ability to perform open heart surgery.
4 Physicians must not preside over less than 50 treatment cycles of in vitro fertilization-embryo transfer (IVF-ET) per physician per year. New personnel must preside over 20 cycles of in vitro fertilization-embryo transfer (IVF-ET) clinical work under the supervision of the supervising physician, and the quality of the work meets the standard and is signed by the supervising physician before they are allowed to work independently.
5. There shall be a male reproduction clinician in the organization or designated to work on male reproduction.
(2) Laboratory personnel
①Laboratory technicians must have a college degree or above in medicine or biology, and at least one of them must have a master's degree or above in medicine or biology, as well as a systematic knowledge of clinical embryology and cell culture skills. Each person must complete at least 50 in vitro fertilization-embryo transfer (IVF-ET) treatment cycles of laboratory operations per year. New personnel must complete 30 cycles of in vitro fertilization-embryo transfer (IVF-ET) under the supervision of the supervising physician, and can work independently only after the supervising physician has signed and passed the test.
②The head of the laboratory must be a senior technical title in medicine or biology or master's degree or above. With cell biology, embryology, genetics and other related disciplines of theory and cell culture skills; master the laboratory skills of assisted human reproduction technology; with laboratory management capabilities.
3) At least one person has skills in semen analysis and processing.
④Institutions that carry out embryo freezing, at least one person has been trained in gamete and embryo freezing technology, and has mastered systematic knowledge of cryogenic freezing biology and skills of gamete and embryo freezing.
5. At least one person in the institution that carries out intracytoplasmic single sperm injection (ICSI) is skilled in microscopic operation and in vitro fertilization-embryo transfer (IVF-ET) laboratory skills.
6. Institutions conducting Pre-implantation Genetic Diagnosis (PGD) of embryos must have skilled embryo micromanipulation and at least one person with theoretical knowledge of medical genetics and single-cell genetic diagnostic techniques.
(3) Nurses Nurses must have a license to practice nursing.
3. Requirements for the premises
(1) The area dedicated to the institution shall not be less than 200m2, and the area used for the in vitro fertilization laboratory and the egg collection room shall not be less than 60m2.
(2) The layout of the premises shall be reasonable, in line with the requirements of cleanliness, and the construction and decoration materials shall be non-toxic, and the chemical and radioactive sources that have an adverse effect on the work shall be avoided.
(3) The workplace shall comply with the hospital building safety requirements and fire safety requirements, to ensure the supply of water and electricity, the workplace should have air disinfection facilities.
(4) Ultrasound room: the area is not less than 10m2, and the environment is in line with the Ministry of Health's Class III standards for medical premises.
(5) Sperm extraction room: adjacent to the semen processing work area.
(6) Egg collection room: for ultrasound-mediated transvaginal egg collection. The area is not less than 15m2. The environment is in accordance with Class II standards for medical establishments of the Ministry of Health.
(7) In vitro fertilization laboratory: with an area of not less than 20m2 and a buffer zone. The environment is in line with the Ministry of Health medical premises Class I standards. It is recommended to set up an air-purification laminar flow room, in which the embryo operation area reaches the standard of Class 100 and has temperature-controlled conditions.
(8) Embryo transfer room: the area is not less than 10m2, and the environment is in line with the Ministry of Health medical premises Class II standards.
4, equipment conditions basic specialized instruments total investment of not less than 1.5 million yuan.
(1) Ultrasound: 2 sets (equipped with vaginal probe and puncture guidance device);
(2) Negative pressure suction: pressure adjustable range of 0-0.02mPa;
(3) gynecological examination bed;
(4) Ultra-clean bench: 1 set each of horizontal airflow type and vertical airflow type. This equipment can be exempted if a laminar flow room is established to meet the Class 100 standard;
(5) Dissecting microscope;
(6) Biological microscope;
(7) Inverted microscope and microscopic operating system (including thermostatic platform);
(8) Semen analysis equipment;
(9) At least 2 carbon dioxide incubators. (infrared carbon dioxide sensor incubator is recommended);
(10) constant temperature platform and insulated test tube rack;
(11) refrigerator;
(12) centrifuge;
(13) routine laboratory instruments: pure water making device, balance, electric drying oven, etc.
(14) gametes/embryos freezing equipment, including : program freezer, liquid nitrogen storage tank and liquid nitrogen transportation tank, etc.
5, other requirements to carry out in vitro fertilization/embryo transfer and its derivatives of the technology of medical institutions must have the following conditions:
(1) cellular/molecular genetic testing conditions;
(2) blood reproductive hormone testing conditions;
(3) the conditions of routine clinical testing (including routine biochemistry, blood and urine, radiological examinations, reproductive immunology examination )
(4) conditions for open surgery;
(5) conditions for hospitalization;
(6) conditions for disinfection of supplies and disposal of dirt.
(2) management
1, rules and regulations of medical institutions should establish the following systems:
(1) staff division of responsibility system.
(2) Sterilization and isolation system.
(3) Material management system.
(4) Special drug management system.
(5) The technical operation routine.
(6) Instrument management system.
(7) Case management system: including patient's identity data, medical history data, treatment records, results and follow-up data, and reported as required.
2. Technical safety requirements
(1) Medical institutions are required to have basic first-aid conditions, equipped with oxygen, endotracheal intubation supplies and commonly used first-aid drugs.
(2) It is recommended to use human albumin or serum substitutes for in vitro fertilization-embryo transfer (IVF-ET) experiments, and its safety must be confirmed.
(3) The experimental materials must be non-toxic, dust-free, and sterile, and meet the appropriate quality standards.
(4) The experimental water must be deionized and ultrapure.
(5) The total number of eggs, congeners and embryos transferred per cycle shall not exceed 3.
(3) Indications and contraindications
1. Indications
(1) Indications for in vitro fertilization-embryo transfer (IVF-ET)
1) Difficulty of sperm-egg encounter due to tubal factors in the female partner.
②Ovulation disorders.
③Endometriosis.
④Few or weak spermatozoa in the male partner.
⑤Unexplained infertility.
⑥Female immune infertility.
(2) Indications for intracytoplasmic single sperm injection (ICSI)
①Severe oligozoospermia, weak and abnormal spermatozoa.
②Obstructive azoospermia.
③Spermatogenesis dysfunction.
④Male immunologic infertility.
⑤In vitro fertilization-embryo transfer (IVF-ET) fertilization failure.
6 Sperm without acrosome or abnormal acrosome function.
(3) Indications for preimplantation genetic diagnosis (PGD) All genetic diseases that can be diagnosed can be applied to preimplantation genetic diagnosis (PGD). It is mainly used for X-linked genetic diseases, single-gene related genetic diseases, chromosomal disorders, and high-risk groups that may give birth to children with the above conditions.
(4) Receiving an egg gift
①Loss of the ability to produce eggs.
②The woman is a carrier or patient of a serious hereditary disease.
③Have obvious factors affecting the quantity and quality of eggs.
(5) Receiving an embryo gift
①The couple loses the ability to produce gametes at the same time.
②The couple has a serious hereditary disease or carries the gene that causes the hereditary disease and cannot produce functioning gametes.
3) An embryo with normal developmental potential cannot be obtained.
2. Contraindications
(1) Any party providing gametes suffers from acute infections of the reproductive and urinary systems and sexually transmitted diseases or has bad habits such as alcoholism or drug addiction.
(2) Any party providing gametes is exposed to teratogenic amount of rays, poisons, medicines and is in the period of action.
(3) Acute infection of reproductive and urinary system and sexually transmitted diseases in the female partner of the couple who receives embryo giving/egg giving, or having bad habits such as alcoholism and drug addiction.
(4) The female partner's uterus does not have the function of pregnancy or serious physical disease cannot bear pregnancy.
(4) Quality standards
1. The institution shall not perform less than 150 cycles of in vitro fertilization-embryo transfer (IVF-ET) per year.
2. The fertilization rate shall not be less than 60%.
3. The clinical pregnancy rate shall not be less than 15 percent in the first year of the institution's existence and 20 percent after the second year.
Third, the code of conduct for technology implementation personnel
1, must strictly abide by the principle of informed, voluntary, signed with the couple informed consent, respect for the patient's right to privacy.
2. When implementing this kind of technology, the national family planning policy must be strictly observed.
3. In the same treatment cycle, gametes, congeners and embryos must come from the same male and the same female.
4. It is prohibited to transfer the gametes, congeners and embryos to others without the patient's knowledge and voluntarily.
5. Sex selection without medical indication is prohibited.
6. It is prohibited to perform sperm and egg union between close relatives.
7. The implementation of surrogacy techniques is prohibited.
8. It is prohibited to perform genetic manipulation on gametes, congeners and embryos.
9. Human cloning is prohibited.
10. It is prohibited to crossbreed human beings with heterologous gametes; it is prohibited to transplant heterologous gametes, synthetics and embryos into women.