What Are the Different Types of Assistive Technology Products?

Assisted reproductive technology is the abbreviation of Assisted Reproductive Technology (ART), which refers to the technology that uses infertile couples to conceive using medical aids, including Artificial Insemination (AI) and In Vitro Fertilization and Embryo Transfer (IVF-ET) and its derivatives.

Assisted reproduction technology

Assisted reproduction technology is
according to
Artificial insemination
(AI) A method of inserting sperm into the female reproductive tract in a non-sexual manner, so that sperm and eggs are naturally combined to achieve conception. The earliest successful AI treatment in humans was John Hunter as a patient with severe hypospadias in 1790
1 Correctly identify the parent-child relationship using IVF-ET technology of fertilization, artificial insemination and egg or embryo, there will be genetic fathers, genetic mothers, foster fathers, foster mothers, and even pregnant mothers and other relatives coexist, who is Child really
Xinhua News Agency, Jinan, September 22 (Reporter Zhang Xiaojing)
Xinhua News Agency, Beijing, November 18 (Reporter
Medical institutions engaged in assisted human reproduction technology (hereinafter referred to as medical institutions) must abide by this specification.
I. Technical Specifications for Artificial Insemination
Artificial insemination is divided into husband semen artificial insemination (AIH) and artificial insemination by Donor Semen (AID) according to the sperm source. Intravaginal Insemination (IVI), Intracervical Insemination (ICI), Intrauterine Insemination (IUI), Intratubal Insemination (ITI), etc. .
(I) Basic requirements
1. Institutional setting conditions
(1) Must be a general or specialized hospital with a license to practice;
(2) The certificate of approval from the Ministry of Health must be obtained for the implementation of artificial insemination by insemination, and the certificate of approval of the health administrative department of the province, autonomous region, or municipality must be obtained for the implementation of artificial insemination of husband's semen;
(3) For the implementation of artificial insemination by insemination, an insemination agreement must be signed with the human sperm bank that has obtained the "Human Sperm Bank Approval Certificate";
(4) Other conditions required by law or the competent authority.
2.Personnel requirements
(1) At least 2 doctors, 2 laboratory staff, and 1 nurses are engaged in reproductive medicine, and all have good professional ethics.
(2) Practitioners must have the qualifications of practitioners, clinical theory and practice of obstetrics and gynecology and reproductive endocrinology, and experience in gynecological ultrasound. The person in charge must have a medical professional and technical title of a deputy high or above. Laboratory staff have the ability to analyze semen and process sperm. The nurse is qualified as a licensed nurse.
3. Site requirements The site includes the waiting room, consultation room and examination room, B-ultrasound room, artificial insemination laboratory, insemination room and other auxiliary areas. The total area must not be less than 100 M2, of which the dedicated areas of artificial insemination laboratory and insemination room are not less than 20 M2 each. In addition, medical institutions must have relevant examination conditions such as gynecological endocrine measurement, imaging examination, genetic examination and so on.
4. Equipment conditions
(1) More than 2 gynecological examination beds;
(2) 1 B-ultrasonic instrument (equipped with vaginal probe);
(3) 1 biological microscope;
(4) 1 small centrifuge;
(5) 100-class ultra-clean workbench;
(6) Carbon dioxide thermostat;
(7) 2-3 liquid nitrogen tanks;
(8) The refrigerator.
The above equipment is required to run well and pass professional inspection.
(Two) management
1. Before insemination, infertile couples must sign the "Informed Consent Form".
2. For insemination, artificial insemination can only obtain the sperm source from the sperm bank holding the approval certificate.
3. Medical institutions must make real-time medical records and follow-up. The subject for artificial insemination should report the pregnancy and offspring to the sperm bank. Records should be kept permanently.
4. Except for the official letter issued by the judiciary and the consent of the relevant parties, the insemination medical institution shall conceal the identity information and detailed address of the couple of the recipient when consulting the file. Non-related personnel are prohibited from checking.
5. Artificial insemination must have complete and sound rules and regulations and a technical operation manual.
6. Self-examination of artificial insemination must be carried out on schedule, and clinical and technical information should be provided to the competent health department.
(Three) indications and contraindications
1.Indications
(1) Artificial insemination of husband's semen:
Male infertility due to oligospermia, weak sperm, abnormal liquefaction, sexual dysfunction, and genital malformations.
Infertility due to cervical mucus secretion, reproductive tract malformations and psychological factors.
Immune infertility.
Infertility of unknown cause.
(2) Artificial insemination by insemination
Azoospermia, severe oligozoospermia, asthenospermia and teratospermia.
Expectation of fertility after vasectomy and failure of reoperation and ejaculation disorders.
The man and / or family have serious genetic diseases that are not suitable for childbearing.
Maternal and child blood type incompatibility can not get a living newborn.
Infertility of unknown cause.
2. Contraindications
(1) The woman's sperm and egg combination disorder caused by the fallopian tube.
(2) The woman has an acute infection of the genitourinary system or a sexually transmitted disease.
(3) The woman suffers from genetic disease, severe physical illness, and mental and psychological disorders.
(4) Birth history of infants with birth defects and confirmed to be caused by female factors.
(5) The woman is in contact with teratogenic radiation, poisons, and drugs.
(6) The woman has bad habits such as alcohol and drug abuse.
(IV) Technical procedures and quality control
1.Technical procedures
(1) Select indications and exclude contraindications.
(2) Artificial insemination can be performed in the natural cycle or the ovulation-promoting cycle, but the application of ovulation-promoting drugs for the purpose of multiple pregnancy is prohibited.
(3) Monitoring the growth and development of follicles by B ultrasound or related hormone levels.
(4) Master the ovulation time in natural menstruation or ovulation-promoting cycle, and artificial insemination in time.
(5) Artificial insemination is feasible. Intravaginal artificial insemination (IVI), intrauterine insemination (ICI), intrauterine insemination (IUI) and intrafallopian tube artificial insemination (ITI). Intrauterine Insemination (IUI) and Intraductal Insemination (ITI) sperm must be washed before they are injected into the uterine cavity.
Husband semen artificial insemination can use fresh semen, for artificial insemination must use frozen semen.
(6) Drugs can be used to support luteal function after artificial insemination.
(7) Biochemical pregnancy was established 14-16 days after artificial insemination, and clinical pregnancy was confirmed by B-ultrasound 5 weeks later.
2.Quality standards
(1) The number of forward-moving sperm injected in the husband's semen artificial insemination is preferably over 1 million.
(2) The activity rate of frozen spermatozoa used for artificial insemination must be higher than 35% after resuscitation.
(3) The clinical pregnancy rate per cycle is not less than 10%.
II. Specification of IVF / embryo transfer and its derivative technology Intracytoplasmic Sperm Injection (ICSI), Preimplantation Genetic Diagnosis (PGD), egg donation, embryo donation, etc.
(I) Basic requirements
1. Institutional setting conditions
(1) It consists of two parts: the clinical department of reproduction (hereinafter referred to as the clinical) and the in vitro fertilization laboratory (hereinafter referred to as the laboratory).
(2) If a sperm bank is built at the same time, it must be managed separately.
(3) Set up the person in charge, clinical person and laboratory person.
(4) There should be no less than 6 reproductive professional and technical personnel, including no less than 4 clinical and laboratory professional and technical personnel, and no less than 2 nursing staff.
(5) Medical technicians in the organization must receive professional technical training.
(6) The technical staff of the organization shall not be concurrently held by persons other than their own units.
(7) A person can only be qualified as a staff member in one institution.
(8) Foreign doctors who come to China or doctors from Taiwan, Hong Kong, and Macao Special Administrative Regions to engage in human assisted reproductive diagnosis and treatment activities in the Mainland must follow the relevant regulations for foreign doctors to practice medical treatment in China or doctors from Taiwan, Hong Kong, and Macau Special Administrative Regions Implementation of management regulations.
2. Staff requirements
(1) Doctor
Clinicians must have a bachelor's degree or above in medical science, and at least one of them must have a medical professional title.
Personnel engaged in reproductive professions must be practitioners in obstetrics and gynaecology or urology with professional titles of intermediate level or above.
The person in charge of the clinic shall be borne by a practicing physician with a senior technical title in the field of reproduction.
At least one doctor has the knowledge and working ability in the following areas: master the clinical professional technical work of female reproductive endocrinology, especially the use of ovulation-promoting drugs and hormone control of the menstrual cycle.
Master gynecological ultrasound technology, and possess the technical ability of follicular ultrasound monitoring and B-ultrasound-assisted vaginal puncture to retrieve eggs.
Capable of open surgery.
Each doctor shall preside over in vitro fertilization-embryo transfer (IVF-ET) for no less than 50 treatment cycles each year. The new personnel must preside over 20 cycles of in vitro fertilization-embryo transfer (IVF-ET) clinical work under the supervision of a superior physician. The quality of the work has reached the standard. They can work independently after being signed by the superior physician.
The institution should have or designate male reproduction clinicians to perform male reproduction work.
(2) Experimental staff
Laboratory technicians must have a bachelor's degree in medicine or biology, at least one of whom must have a master's degree in medicine or biology, and have systematic clinical embryology knowledge and cell culture skills. Each person completes at least 50 experimental procedures of IVF-ET treatment cycles per year. The new personnel must complete the 30 in vitro fertilization-embryo transfer (IVF-ET) cycle experiments under the supervision of the superior doctor, and the superior doctor can work independently after signing the qualification.
The person in charge of the laboratory must be a person with a senior technical title or a master's degree in medicine or biology. Possess theory and cell culture skills in cell biology, embryology, genetics and other related disciplines; master laboratory skills in human assisted reproductive technology; have laboratory management capabilities.
At least one person has the skills of semen analysis and processing.
At least one person has been trained in gamete and embryo freezing technology, and has a systematic knowledge of cryogenic freezing biology and gamete and embryo freezing skills.
At least one person in the organization that carries out intracytoplasmic sperm injection (ICSI) has proficient microscopy and in vitro fertilization-embryo transfer (IVF-ET) laboratory skills.
Institutions conducting pre-implantation embryo genetic diagnosis (PGD) must have skilled embryo micromanipulation skills, and at least one person must have knowledge of medical genetics theory and single-cell genetic diagnostic technology.
(3) The nurse must have a nurse license.
3. Place requirements
(1) The area dedicated to the institution is not less than 200m2, and the area used for the IVF laboratory and the egg collection room is not less than 60m2.
(2) The layout of the site must be reasonable, meet cleanliness requirements, non-toxic building and decoration materials, and avoid chemical and radioactive sources that have an adverse effect on work.
(3) The workplace must meet the requirements of hospital construction safety and fire protection, ensure the supply of water and electricity, and each workplace should be equipped with air disinfection facilities.
(4) Ultrasound room: the area is not less than 10m2, and the environment meets the Class III standard of the medical place of the Ministry of Health.
(5) Sperm collection room: It is close to the semen processing work area.
(6) Egg retrieval room: for transvaginal egg retrieval mediated by B ultrasound. The area is not less than 15m2. The environment meets the Class II standard for medical places of the Ministry of Health.
(7) In vitro fertilization laboratory: the area is not less than 20m2, and it has a buffer zone. The environment meets the Class I standard of the medical place of the Ministry of Health, and it is recommended to set up an air purification laminar flow chamber, in which the embryo operation area reaches a standard of 100, and has temperature control conditions.
(8) Embryo transfer room: the area is not less than 10m2, and the environment meets the Class II standard of the medical place of the Ministry of Health.
4. Equipment conditions The total investment of basic special instruments is not less than 1.5 million yuan.
(1) B-ultrasound: 2 (equipped with vaginal probe and puncture guidance device);
(2) Negative pressure suction device: pressure adjustable range 0-0.02mPa;
(3) Gynecological examination bed;
(4) Ultra-clean workbench: one for horizontal airflow and one for vertical airflow. This equipment can be eliminated if the laminar flow chamber is established up to the 100 level standard;
(5) dissection microscope;
(6) biological microscope;
(7) Inverted microscope and microscope operating system (including constant temperature platform);
(8) Semen analysis equipment;
(9) At least 2 carbon dioxide incubators. (Infrared carbon dioxide sensor incubator is recommended);
(10) Constant temperature platform and insulation test tube rack;
(11) refrigerator;
(12) Centrifuge;
(13) Laboratory conventional instruments: pure water production equipment, balances, electric heating ovens, etc .;
(14) Gamete / embryo freezing equipment, including: program freezer, liquid nitrogen storage tank and liquid nitrogen transport tank, etc.
5. Other medical institutions that require in vitro fertilization / embryo transfer and its derivative technologies must have the following conditions:
(1) Cell / molecular genetic testing conditions;
(2) blood reproductive hormone detection conditions;
(3) Routine clinical test conditions (including routine biochemical, hematuria routine, radiological examination, reproductive immunological examination);
(4) open surgery conditions;
(5) Hospitalization conditions;
(6) Conditions for disinfection of supplies and disposal of dirt.
(Two) management
1. Regulations Medical institutions shall establish the following systems:
(1) Staff responsibility system.
(2) Disinfection and isolation system.
(3) Material management system.
(4) Special drug management system.
(5) Various technical operation routines.
(6) Instrument management system.
(7) Medical record management system: including the patient's identity data, medical history data, treatment history records, results and follow-up data, and report as required.
2. Technical safety requirements
(1) Medical institutions are required to have basic first-aid conditions, equipped with oxygen inhalation, tracheal intubation supplies and commonly used first-aid drugs.
(2) It is recommended to use human albumin or serum substitute for in vitro fertilization-embryo transfer (IVF-ET) experiments, and its safety must be confirmed.
(3) The test materials must be non-toxic, dust-free, sterile, and meet the corresponding quality standards.
(4) Deionized ultrapure water shall be used as the experimental water.
(5) The total number of eggs, zygotes, and embryos transferred per cycle is not more than 3.
(Three) indications and contraindications
1.Indications
(1) Indications for IVF-ET
The sperm and egg are difficult to meet due to the fallopian tube.
Ovulation disorders.
endometriosis.
The man has few and weak spermatozoa.
Infertility of unknown cause.
Female immune infertility.
(2) Intracytoplasmic sperm injection (ICSI) indications
Severe oligo, weak, teratozoospermia.
Obstructive azoospermia.
Spermatogenic dysfunction.
Male immune infertility.
IVF-ET failed to fertilize.
Sperm have no acrosome or acrosome dysfunction.
(3) Pre-implantation embryo genetic diagnosis (PGD) indications Any genetic disease that can be diagnosed can be applied to pre-implantation embryo genetic diagnosis (PGD). It is mainly used for X-linked genetic diseases, single-gene related genetic diseases, chromosomal diseases, and high-risk groups of children who may have more than children.
(4) Accept egg donation
Loss of ability to produce eggs.
The woman is a carrier or patient of a severe inherited disease gene.
There are obvious factors that affect the number and quality of eggs.
(5) Accept embryo donation
Both spouses lose the ability to produce gametes at the same time.
Both spouses have severe hereditary diseases or carry genes that cause hereditary diseases and cannot produce normal gametes.
embryos with normal developmental potential cannot be obtained.
2. Contraindications
(1) Any party providing gametes suffers from acute reproductive, urinary tract infections and sexually transmitted diseases, or has bad habits such as alcohol and drug abuse.
(2) Any one of the gametes is exposed to teratogenic radiation, poisons, and drugs and is in the period of action.
(3) The husband and wife who received the gift of the embryo / egg donated acute reproductive and urinary system infections and sexually transmitted diseases, or had bad habits such as alcohol and drug abuse.
(4) The woman's uterus does not have pregnancy function or severe physical illness cannot bear pregnancy.
(Four) quality standards
1. The in vitro fertilization-embryo transfer (IVF-ET) performed by the institution shall not be less than 150 cycles per year.
2. The fertilization rate must not be lower than 60%.
3. The clinical pregnancy rate shall not be less than 15% in the first year of establishment, and not less than 20% after the second year.
3. Code of Conduct for Technical Implementers
1. Must strictly abide by the principle of informed and voluntary, sign the informed consent with the couple, and respect the patient's right to privacy.
2. When implementing such technologies, they must strictly abide by the national family planning policy.
3. In the same treatment cycle, gametes, zygotes and embryos must be from the same male and female.
4. It is forbidden to transfer gametes, zygotes, embryos to others without the patient's knowledge and willingness.
5. Sex selection without medical indication is prohibited.
6. Sperm and egg bonding between close relatives is prohibited.
7. Prohibition of surrogacy technology.
8. Genetic manipulation of gametes, zygotes, and embryos is prohibited.
9. It is forbidden to clone people.
10. It is forbidden to hybridize humans with heterogeneous gametes; it is forbidden to perform heterogeneous gametes, zygotes and embryos for female female transplantation.

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