Assisted Reproductive Technology (ART) includes In Vitro Fertilization and Embryo Transfer (IVF-ET) and its derivative technologies and Artificial Insemination (AI). Insemination (AI) two categories. All types of medical institutions and family planning services engaged in human assisted reproductive technology (hereinafter referred to as institutions) shall comply with this specification.
A, in vitro fertilization – embryo transfer and its derivative technology specifications
In vitro fertilization – embryo transfer and its derivative techniques currently include in vitro fertilization – embryo transfer, gamete or gamete intrafallopian tube transfer, intracytoplasmic single sperm microinjection, embryo freezing and thawing, pre-implantation embryo genetic diagnosis.
(A) Basic requirements.
1.Institutional setup conditions
(1) must be a general hospital or specialist hospital holding the “Medical Institution Practice License” or a family planning technical service institution above the provincial level (including the provincial level) holding the “Family Planning Technical Service Institution Practice License”;
(2) the Chinese People’s Liberation Army medical institutions to carry out in vitro fertilization – embryo transfer and its derivative technology, according to the two “methods”, the provincial, autonomous regions, municipalities directly under the Central Health Administrative Department or the General Logistics Department of Health Science and Technology Department to organize expert verification, review and approval by the State Ministry of Health;
(3) Sino-foreign joint ventures, cooperative medical institutions must hold both the Ministry of Health approval certificate and the former Ministry of Foreign Trade and Economic Cooperation (now the Ministry of Commerce) issued by the “Foreign Investment Enterprise Approval Certificate”;
(4) institutions must have obstetrics and gynecology and male clinical and obstetrics and gynecology inpatient open-heart surgery technology and conditions;
(5) reproductive medicine institutions by the reproductive medicine clinical (hereinafter referred to as clinical) and in vitro fertilization laboratory (hereinafter referred to as laboratory) two parts;
(6) institutions must have the technology of selective fetal reduction;
(7) institutions must have the technology and conditions for embryo freezing, preservation, and resuscitation;
(8) institutions such as human sperm bank at the same time, can not be located in the same department, must be managed separately from the reproductive medicine institutions;
(9) where the plan to carry out human assisted reproductive technology institutions must be by the provincial, regional and municipal health administrative departments according to regional planning, medical needs to be the first review, and submitted to the Ministry of Health for approval of the preparation. After the completion of the preparation by the Ministry of Health experts to organize pre-access review, a year after the trial run and then formal access review;
(10) The implementation of in vitro fertilization – embryo transfer and its derivative technology must obtain the approval certificate from the Ministry of Health.
2. Staffing requirements
The institution has a general director, clinical director and laboratory director, the clinical director and laboratory director may not be the same person.
Reproductive medicine institutions must have no less than 12 full-time technical staff, including no less than 6 clinicians (including a male practitioner), no less than 3 laboratory technicians, and no less than 3 nursing staff. The above-mentioned personnel must be designated by the Ministry of Health medical institutions for professional and technical training in reproductive medicine.
Foreign nationals, Taiwan, Hong Kong and Macao Special Administrative Region of China to the Mainland to engage in human assisted reproduction treatment activities must be implemented in accordance with the relevant national regulations.
(1) Clinicians
① full-time clinicians must have a bachelor’s degree in medicine and have obtained intermediate technical titles or have a master’s degree in reproductive medicine, obstetrics and gynecology or male urologists;
② clinical director must be engaged in the reproductive specialty with senior technical title of obstetrician and gynecologist;
③ clinicians must have the knowledge and ability to work in the following areas.
master the clinical expertise of female reproductive endocrinology, especially the use of ovulation-promoting drugs and hormonal regulation of the menstrual cycle;
master gynecological ultrasound technology, and have the technical ability of follicular ultrasound monitoring and B ultrasound-mediated vaginal puncture for egg retrieval, with the ability to open surgery; with the ability to deal with various complications of human assisted reproductive technology;
④ institutions should be equipped with full-time male clinicians, mastering the basic theory of male reproductive medicine and clinical expertise.
(2) laboratory technicians
① embryo culture laboratory technicians must have a bachelor’s degree or college degree in medicine or biology and have intermediate technical titles;
② laboratory personnel in charge of medical or biological professional senior technical title, with cell biology, embryology, genetics and other related disciplines of theory and cell culture skills, mastering the laboratory skills of human assisted reproduction technology, with laboratory management skills;
③At least one person has the skills to handle semen according to the standard procedures of the World Health Organization semen analysis;
④At least one person has received training in sperm and embryo freezing and resuscitation techniques in an institution designated by the Ministry of Health, and has systematically mastered sperm and embryo freezing and resuscitation skills;
⑤ to carry out intracytoplasmic single sperm microinjection technology, at least one person in the Ministry of Health designated institutions have been trained in this technology, and skilled microscopic operation and in vitro fertilization and embryo transfer laboratory skills;
(6) to carry out preimplantation embryo genetic diagnosis of the institution, there must be specialized personnel trained in polar body or embryonic oocyte biopsy techniques, skilled in the operational skills of the technology, master theoretical knowledge of medical genetics and single-cell genetic diagnosis techniques, the institution must have genetic counseling and prenatal diagnosis technology conditions.
(3) Nurse
Nurses must have a nurse practitioner certificate, trained in reproductive medicine nursing work, the person in charge of nursing must have intermediate technical titles.
3.Place requirements
(1) places must include waiting areas, treatment rooms, examination rooms, sperm extraction rooms, semen processing rooms, data files, cleaning rooms, buffer areas (including changing rooms), ultrasound rooms, embryo culture rooms, egg retrieval rooms, in vitro fertilization laboratories, embryo transfer rooms and other auxiliary places;
(2) the total area used for reproductive medicine medical activities is not less than 260 square meters;
(3) the layout of the place must be reasonable, in line with clean requirements, construction and decoration materials required non-toxic, should avoid the work of adverse effects on chemical and radioactive sources;
(4) the workplace must meet the hospital building safety requirements and fire requirements, to protect the water and electricity supply. Each workroom should have air disinfection facilities;
(5) the main place requirements
① ultrasound room: the use of an area of not less than 15 square meters, the environment in line with the Ministry of Health medical premises III standard;
② sperm extraction room: adjacent to the semen processing room, the use of an area of not less than 5 square meters, and hand-washing equipment;
③ semen processing room: the use of an area of not less than 10 square meters;
④ egg retrieval room: for ultrasound-mediated transvaginal egg retrieval, the use of an area of not less than 25 square meters, the environment in line with the Ministry of Health medical premises II standards;
⑤ In vitro fertilization laboratory: the use area is not less than 30 square meters, with buffer area. The environment is in accordance with the Ministry of Health’s Class I standards for medical sites, and it is recommended to set up an air purification laminar flow room. The embryo operation area must meet the class 100 standard;
(6) Embryo transfer room: the use area is not less than 15 square meters, and the environment is in line with the Ministry of Health’s medical premises class II standard.
4.Equipment conditions
(1) Ultrasound: 2 sets (equipped with vaginal probe and puncture guidance device);
(2) Negative pressure suction device;
(3) Gynecological bed;
(4) Ultra-clean table: 3 sets;
(5) Dissecting microscope;
(6)Biological microscope;
(7) Inverted microscope (with thermostatic platform);
(8) Semen analysis equipment;
(9) carbon dioxide incubator (at least 3 units);
(10) carbon dioxide concentration measurement instrument;
(11) constant temperature platform and constant temperature test tube rack;
(12) Refrigerator;
(13) Centrifuge;
(14) routine laboratory instruments: pH meter, osmometer, balance, electric drying oven, etc;
(15) gametes and embryos freezing equipment including: freezers, liquid nitrogen storage tanks and liquid nitrogen transport tanks, etc.
Declared to carry out intracytoplasmic single sperm microinjection technology institutions, must have a microscopic manipulator.
5.Other requirements
To carry out in vitro fertilization and embryo transfer and its derivative technology institutions, must also have the following conditions.
(1) routine clinical tests (including routine biochemical, blood and urine routine, imaging, reproductive immunology examination);
(2) Reproductive endocrine laboratory and its related equipment;
(3) cytogenetic and molecular genetics diagnostic laboratory and its related equipment; if the institution to carry out pre-implantation embryo genetic diagnosis, must also have prenatal diagnostic technology accreditation;
(4) open surgery conditions;
(5) inpatient treatment conditions;
(6) supplies sterilization and dirt disposal conditions.
(B) management.
1, the implementation of in vitro fertilization and embryo transfer and its derivative technology institutions, must comply with the provisions of national population and family planning laws and regulations, and with the infertile couple to sign the relevant technology “informed consent” and “multiple pregnancy reduction consent form”;
2. The institution must carefully check in advance the ID cards, marriage certificates and original birth certificates of infertile couples in accordance with national population and family planning laws and regulations, and keep their copies for record; couples in foreign marriages and foreigners should present their passports and marriage certificates and keep their copies for record;
3, the institution must conduct self-examination of the work on a regular basis, and provide the Ministry of Health with the necessary information and annual reports as required;
4. The medical records of the institution and its related records shall be strictly managed according to the requirements of the Ministry of Health and the State Administration of Traditional Chinese Medicine, “Notice on the Issuance of the Regulations on the Management of Medical Records of Medical Institutions”, No. 193 [2002];
5, the implementation of sperm donor in vitro fertilization and embryo transfer and its derivative technology, must provide timely and accurate feedback to the human sperm bank of the recipient’s pregnancy and offspring and other related information;
6.Rules and regulations
The institution shall establish the following systems
(1) Reproductive medicine ethics committee work system;
(2) Case management system;
(3) Follow-up system;
(4) Staff division of responsibility system;
(5) Quality control system for experimental materials in contact with gametes and embryos;
(6) Technical operation routines;
(7) Management system of special drugs;
(8) Instrument management system;
(9) Sterilization and isolation system;
(10) material management system.
7, technical safety requirements
(1) require institutions with basic first aid conditions, including oxygen supply, tracheal intubation and other supplies and commonly used emergency drugs and equipment, etc.;
(2) institutions using anesthesia techniques must be equipped with the appropriate monitoring, resuscitation equipment and personnel;
(3) experimental materials must be non-toxic, dust-free, sterile, and meet the appropriate quality standards;
(4) Experimental water must be deionized ultrapure water;
(5) The total number of embryos to be transferred in each cycle shall not exceed 3, among which the number of embryos to be transferred in the first cycle for women under 35 years of age shall not exceed 2;
(6) Supplies in contact with gametes or embryos must be single-use consumables;
(7) The implementation of in vitro fertilization and embryo transfer of donor sperm and its derivative techniques must be carried out with reference to the relevant provisions of artificial insemination.
(C) indications and contraindications.
1, indications
(1) in vitro fertilization – embryo transfer indications
① female gamete transport disorders caused by various factors;
(ii) Ovulation disorder;
(3) Endometriosis;
④Low or weak spermatozoa in the male partner;
⑤Uncertain infertility;
(6) Immune infertility.
(2) Indications for intracytoplasmic single sperm microinjection
①Severe oligospermia, weak spermatozoa and teratospermia;
(ii) irreversible obstructive azoospermia;
③Spermatogenic dysfunction (excluding those caused by genetic defects);
④Immune infertility;
⑤ In vitro fertilization failure;
(6) Abnormal sperm acrosome;
(7) Pre-implantation embryo genetic examination is required.
(3) Indications for preimplantation embryo genetic diagnosis
At present, it is mainly used for single gene related genetic diseases, chromosomal diseases, sex-linked genetic diseases and high-risk groups who may have abnormal children.
(4) Indications for egg donation
① Loss of ability to produce eggs;
②The female partner is a carrier or patient of a serious hereditary disease;
(3) Significant factors affecting the quantity and quality of eggs.
(5) Basic conditions for egg donation
(1) Egg donation is a humanitarian act and it is prohibited for any organization or individual to recruit egg donors in any form for commercial egg donation;
(2) Egg donation is limited to eggs left over from assisted human reproduction treatment cycles;
③The egg donor must undergo relevant health examination (refer to sperm donor health examination standards);
④The donor should be fully informed of the use, rights and obligations of the donated eggs and should sign an informed consent form;
(5) Each donor can only give birth to a maximum of 5 women;
(6) The clinical follow-up rate of egg donation must reach 100%.
2. Contraindications
(1) In vitro fertilization-embryo transfer and its derivative techniques should not be performed if one of the following conditions exists
(1) Any party suffering from serious mental illness, acute infection of the genitourinary system, or sexually transmitted diseases;
② suffering from the “Maternal and Child Health Law” is not suitable for childbirth, currently unable to perform pre-implantation genetic diagnosis of hereditary diseases;
③ either party has a serious drug addiction and other bad habits;
④ any party exposed to teratogenic amounts of radiation, toxins, drugs and in the period of action.
(2) The uterus of the female party does not have the function of pregnancy or serious physical disease cannot bear pregnancy.
(iv) Quality standards.
1, in order to effectively protect the interests of patients, safeguard the health rights of women and children, improve the quality of the population, strictly prevent the industrialization and commercialization of human assisted reproductive technology, as well as to ensure that the technology is more standardized and orderly, any reproductive institutions implemented in vitro fertilization and embryo transfer and its derivative technology shall not exceed 1000 egg retrieval cycles per year;
2, the agency’s follow-up rate for in vitro fertilization – embryo transfer births must not be less than 95%;
3. The fertilization rate for in vitro fertilization shall not be less than 65%, and the fertilization rate for intracytoplasmic single sperm microinjection shall not be less than 70%;
4. The clinical pregnancy rate for egg retrieval cycles shall not be less than 15% in the first year of the institution’s establishment and 20% after the second year; the clinical pregnancy rate for transfer cycles of frozen-thawed embryos shall not be less than 10% (clinical pregnancy rate for transfer cycles = (number of clinical pregnancies/number of transfer cycles) x 100%);
5, for multiple pregnancies must be implemented to reduce fetal surgery, to avoid double births, three and more than three pregnancy delivery is strictly prohibited.
Second, artificial insemination technical specifications
Artificial insemination technology according to the source of sperm is divided into husband artificial insemination and artificial insemination for sperm technology.
(A) the basic requirements.
1, the institutional setting conditions
(1) must hold a “medical institution license” general hospitals, specialty hospitals or hold a “family planning technical services license” of family planning technical services;
(2) the implementation of artificial insemination for sperm must be approved by the Ministry of Health, the implementation of artificial insemination of husband sperm must be approved by the provincial, autonomous regions, municipalities directly under the Central Health Administration and reported to the Ministry of Health for the record;
(3) the Chinese People’s Liberation Army medical institutions to carry out artificial insemination technology, according to the two “methods”, the application for the development of artificial insemination technology for husband sperm institutions, by the province, autonomous region, municipality directly under the Central Health Department or the General Logistics Department of Health Science and Technology Department to organize expert demonstration, review, examination and approval, and reported to the State Ministry of Health for the record; for the application to carry out artificial insemination of sperm donor medical institutions, by the province, autonomous region, the Municipalities directly under the jurisdiction of the Department of Health or the General Logistics Department of Health science and technology department to organize expert verification, review and approval, and reported to the State Ministry of Health;
(4) Sino-foreign joint ventures, cooperative medical institutions, must hold both the Ministry of Health approval certificate and the former Ministry of Foreign Trade and Economic Cooperation (now the Ministry of Commerce) issued by the “Foreign Investment Enterprise Approval Certificate;
(5) the implementation of artificial insemination of sperm donor institutions, must hold the “human sperm bank approval certificate” from the human sperm bank to obtain the sperm source and sign a sperm supply agreement, and the obligation to provide timely sperm artificial insemination and accurate feedback information to the sperm supply unit; agreement should specify the responsibilities of both parties;
(6) with laws, regulations or other conditions required by the competent authorities.
2, personnel requirements
(1) At least two full-time physicians, two laboratory staff and one nurse engaged in reproductive medicine, and all have good professional ethics;
(2) Practitioners must have a license to practice medicine;
(3) the institution must designate a full-time person in charge, the person in charge must have a senior technical title of obstetrics and gynecology practitioner;
(4) The physicians in the institution should have theoretical and practical experience in clinical obstetrics and gynecology and reproductive endocrinology, and have qualifications and experience in gynecologic ultrasound technology;
(5) laboratory staff should have training experience and practical skills in handling semen according to the standard procedures of the World Health Organization semen analysis;
(6) Nurses should be qualified to practice nursing;
(7) while carrying out in vitro fertilization – embryo transfer technology institutions, must designate a full-time person in charge, other personnel can be used concurrently.
3, place requirements
Places include waiting rooms, consultation rooms, examination rooms, ultrasound rooms, artificial insemination laboratories, insemination rooms and other auxiliary areas, the total area used shall not be less than 100 square meters, including artificial insemination laboratories of not less than 20 square meters and insemination rooms dedicated area of not less than 15 square meters; while carrying out artificial insemination and in vitro fertilization and embryo transfer institutions, waiting rooms, consultation rooms, examination rooms and ultrasound rooms can be set up without a single But artificial insemination room and artificial insemination laboratory must be dedicated, and the use of an area of not less than 20 square meters each; in addition, the technical service institutions must have gynecological endocrine determination, imaging, genetics and other related inspection conditions.
4, equipment conditions
(1) more than 2 gynecological examination beds;
(2) ultrasound machine 1 (configured vaginal probe);
(3) 1 biological microscope;
(4) 1 set of centrifuge;
(5) 1 set of ultra-clean bench of class 100;
(6) carbon dioxide incubator 1;
(7) more than 2 liquid nitrogen tanks;
(8) a refrigerator;
(9) semen analysis equipment;
(10) 1 water bath;
(11) and semen contact utensils, etc. must use non-toxic disposable supplies.
The above equipment requires good operation, professional inspection qualified.
(II) Management.
1, before the implementation of insemination, infertile couples must sign the “informed consent” and “multiple pregnancy reduction consent form”;
2, artificial insemination of sperm can only be obtained from the human sperm bank with a certificate of approval from the Ministry of Health;
3, the institution must do a good job of writing the medical records of infertile couples in a timely manner and strictly manage them in accordance with the “Medical Records Management Regulations for Medical Institutions”, and each recipient should be followed up;
4, the implementation of artificial insemination of sperm donor institutions, must feedback to the human sperm bank pregnancy, offspring and whether the recipient of frozen semen after the use of clinical information on sexually transmitted diseases, etc., the record file should be kept permanently;
5, strict control of each sperm donor frozen semen can only conceive a maximum of five women;
6, in addition to the judicial organs issued an official letter or the relevant parties have good reason to agree to access, any other units and individuals are refused access to the files of the two sperm donors and recipients; indeed, due to work needs and other special reasons must access the files, then must be approved by the person in charge of the insemination institution, and conceal the social identity information of the two donors and recipients;
7, artificial insemination must have perfect, sound rules and regulations and technical operation manual and effectively put into practice;
8, artificial insemination must be self-examination of the situation on a regular basis, as required to provide the necessary information and annual reports to the health administrative approval department.
(C) indications and contraindications.
1, artificial insemination of husband sperm
(1) indications
① male infertility due to oligospermia, weak sperm, liquefaction abnormalities, sexual dysfunction, genital malformations, etc.;
②Cervical factor infertility;
(3) Infertility due to deformity of the reproductive tract and psychological factors such as inability to have intercourse;
④Immune infertility;
(5) Infertility of unknown origin.
(2) Contraindications
(1) One of the men and women suffering from acute genitourinary infections or sexually transmitted diseases;
(2) One of the parties is suffering from serious genetic, physical or psychological disorders;
(3) one party is exposed to teratogenic amount of radiation, toxins, drugs and in the period of action;
④ one party has a drug addiction and other serious bad habits.
2.Artificial insemination by sperm donation
(1)Indications
① irreversible azoospermia, severe oligospermia, weak spermia and teratospermia;
(2) Failure of vasectomy reversal;
(3) Ejaculation disorder;
④In the indications ①②③, except for irreversible azoospermia, the medical staff must clearly explain to the patients who require donor insemination that they may have their own blood relatives through intracytoplasmic single sperm microinjection, and if the patients still insist on renouncing their right to conceive through intracytoplasmic single sperm microinjection, they must sign an informed consent form before they can use the technique. Donor insemination for conception;
⑤ The male partner and/or the family has a serious hereditary disease that is unsuitable for fertility;
(6) The mother and child are not compatible with the blood type to obtain a viable newborn.
(2) Contraindications
(1) The female partner has acute genitourinary infection or sexually transmitted disease;
②The female partner suffers from serious genetic, physical or mental illnesses;
(3) The woman is exposed to teratogenic amount of radiation, toxins, drugs and in the period of action;
④ the woman has a drug addiction and other bad habits.
(D) Technical procedures and quality control.
1.Technical procedures
(1) Strictly grasp the indications and exclude contraindications;
(2) Artificial insemination can be performed under the natural cycle or pharmacological ovulation cycle, but the use of ovulation-promoting drugs for the purpose of multiple pregnancy is strictly prohibited;
(3) Monitoring of follicular growth and development by ultrasound and hormone levels;
(4) Timing of ovulation and timely insemination;
(5) The sperm for artificial insemination must be washed and separated, and the total number of forward-moving sperm must not be less than 20×106 for intracervical artificial insemination and 10×106 for intrauterine insemination;
(6) After artificial insemination, the luteal function can be supported by drugs;
(7) Diagnosis of biochemical pregnancy 14-16 days after insemination and clinical pregnancy confirmed by ultrasound at 5 weeks;
(8) Multiple pregnancies must be treated by selective reduction at an institution that is equipped for selective reduction;
(9) If the institution performing artificial insemination by sperm donation does not have the conditions and technology for selective reduction, it must sign an agreement with the institution with the technology to use the reduction technology to ensure the effective implementation of selective reduction and avoid multiple births.
2.Quality standards
(1) Frozen semen for artificial insemination by sperm donor, not less than 40% of sperm with forward motion after recovery ;
(2) cycle clinical pregnancy rate of not less than 15% (cycle clinical pregnancy rate = number of clinical pregnancy / number of artificial insemination cycles × 100%).
Third, the implementation of the code of conduct for technical personnel
(a) must strictly comply with national laws and regulations on population and family planning;
(B) must strictly comply with the voluntary principle of informed consent and informed choice;
(C) must respect the patient’s right to privacy;
(d) Prohibit gender selection without medical indication;
(e) prohibit the implementation of surrogacy techniques;
(f) prohibit the implementation of embryo gift;
(vii) prohibit the implementation of human oocyte plasma transfer and nuclear transfer technology for the purpose of treating infertility;
(H) prohibit the hybridization of human and heterozygous gametes; prohibit the transplantation of heterozygous gametes, congeners and embryos in humans; prohibit the transplantation of human gametes, congeners and embryos in heterozygotes;
(ix) prohibit genetic manipulation of human gametes, conspecifics and embryos for reproductive purposes;
(j) prohibit the implementation of inter-parental sperm and egg union;
(xi) The gametes and congeners must come from the same male and the same female in the same treatment cycle;
(xii) The transfer of gametes, congeners and embryos to another person or for scientific research without the patient’s knowledge and volition is prohibited;
(XIII) prohibit the implementation of human assisted reproductive technology to couples and single women who do not meet the provisions of national population and family planning laws and regulations;
(XIV) prohibit experimental research on human chimeric embryos;
(xv) prohibit the cloning of human beings.