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The learning objectives of this topic in Fellowship in Reproductive Medicine would be introducing the concept what is ART, what are the objectives of the art, what is the provisions of the ART Act currently, what are the salient points, what are the merits and demerits and finally interesting cases.
The ancient Hindu culture has various references to assisted reproduction and therefore we can think that there is a tradition which is an integral part of our history since time immemorial. The classic example of Mahabharata which is bound with several instances of assisted reproductive techniques. King Pandu who could not have sexual intercourse with his wife since he could not father offsprings and Dharma demanded children. His senior wife Kunti quoted that Dharma permitted demigods to impregnate his wives to have children who would later be known as Pandavas.
The five warrior kings of the Mahabharata therefore originated from the Ashwini gods, the Pancha Pandavas, Yama, Vayu, and Indra.Furthermore, the Mahabharata depicts Gandhari's lengthy gestation, following which she gave birth to a lump of immovable flesh, and names 100 Kauravas and one daughter born to her and Dhritarashtra.According to mythology, the Gandhari narrative did not conclude with a stillbirth; instead, 101 offspring were born one at a time after the fetus was split up into 100 parts and placed in jars with ghee added and allowed to incubate.
This narrative is strongly reminiscent of the IVF with the multiple pregnancies that commonly occur with it. So here we have the Gandhari and there we pictorial representation of so many babies coming out of the eggs.
What is ART?
ART, which stands for Assisted Reproductive Technology, is a method used to help people who are unable to conceive naturally due to infertility. This process involves various fertility treatments that work with both eggs and sperm. Simply put, it's a type of treatment that deals with gametes, which are the reproductive cells—eggs from the female and sperm from the male. The process usually begins by taking the eggs from the woman's ovaries. Once the eggs are obtained, they are combined with sperm in a controlled environment to allow fertilization and the development of embryos. After the embryos are formed, they are carefully placed back into the woman's uterus through a process called embryo transfer. This entire process is designed to increase the chances of a successful pregnancy.
In-vitro fertilization, or IVF, is the most widely used and effective method among all forms of assisted reproductive technology, which is commonly referred to as ART. ART involves various techniques such as using eggs from a donor, sperm from a donor, or embryos that have been previously frozen. So, when looking at the laws related to ART, it's important to understand all the situations that are covered by these laws. Just like doctors need to know these things for their work, people who want to do IVF should also know the specific requirements IVF training courses eligibility. This helps make sure they are ready to deal with the medical, ethical, and legal parts of helping with reproduction.
So with its growing use ART has helped millions of infertile couples around the world and it goes without saying that it is a boon for these infertility couple. The success of these depends on many factors like age, the number of oocytes that are already there, the number of oocytes retrieved, the fertilization, implantation etc. The risks as we all know of any kind of ART is multiple gestations, preterm birth, preeclampsia and it's a huge emotionally challenging roller coaster for the couple. So, the duties of the clinics ART clinics and ART banks that has been defined now is they can do stimulation of ovaries, egg retrieval from ovaries, fertilization of eggs, embryo culture, freezing of excess embryos, embryo transfer and also further manage the pregnancy.
The ART at the salient points are a national and state board have been constituted for accreditation, supervision and regulation of services of ART clinics and banks in the country. So, the nation will have a board and every state also should have a board. There are two levels of ART clinics.
A level 1 ART clinic is where initial tests are done to find out the type and reason for infertility, and only IUI treatments can be provided. On the other hand, a level 2 ART clinic offers all the more detailed tests, diagnoses, and treatments related to ART. These clinics are also allowed to take part in research.
Now, the ART banks they will be responsible for screening, collection and registration of the semen donor and cryopreservation of sperms. The screening and registration of oocyte donors, they may operate as semen banks or oocyte banks or both and these ART banks will maintain records and data of all donors and will regularly update the national registry. Now, for application for registration needs to be submitted to the appropriate authority and the fees for which is 1 lakh for level 1 ART clinic, 5 lakhs for level 2 ART clinic and 1 lakh for the ART bank.
Every application for renewal of registration shall be accompanied by an application fee as 1 lakh for level 1 ART clinic, 5 lakhs for level 2 ART clinic and 1 lakh for the ART bank. So, even for renewal it is the same fees. Sperm and oocyte donors should be tested for all the serology should be done for all the viral diseases like HIV type 1 and 2, hepatitis B virus, hepatitis C virus, tryponema pallidum through VDRL and chlamydia testing.
An insurance coverage for a period of 12 months in favour of the oocyte donor needs to be done by the commissioning couple. Every ART clinic and or or bank should maintain records of the name and addresses of the couple or the woman who underwent ART procedures or tests and the date on which they first reported for the procedure. So, documentation is extremely important.
The duties of ART clinic, they should ensure that all unused gametes or embryos should be preserved by the clinic for use on the same recipient and shall not be used for any other couple or women which would be a dangerous breach. ART clinics shall allow cryopreservation of oocytes sperms for oncofertility patients undergoing treatment for durations longer than 10 years with permission from the national board. While retrieving oocytes, efforts should be made to retrieve not more than 7 oocytes during one cycle from the donor.
The consent forms that are to be maintained are consent form signed by the couple or women, consent for intrauterine insemination either with the husbands or donor sperm, consent for IUI that is husband and donor sperm, consent for freezing embryos, consent for freezing gametes, consent for withdrawal and consent for oocyte retrieval. The other consent forms that have to be maintained by the ART banks are record of use of donor gametes, results of screening of semen donors and oocyte donors, consent form for the donor of sperm, consent form for the donor of oocyte. Information about the number of donors that is the sperm or oocyte donors screened, maintained and supplied to the clinic should be maintained and be provided to the national registry regularly.
Prior to the pore processing of patient gametes or embryos intended for use in the treatment or storage, the center must carry out the tests like HIV 1 and 2, anti-HIV 1 and 2, hepatitis B, HBsAg, anti-HBc, hepatitis C and anti-HCV antibodies. Semen culture should be carried out on all semen samples before preservation. The ART bank should devise a system of storage of gametes and embryos clearly separating quarantined, unscreened, tested negative and tested positive.
Cryo cans should be fitted with local alarms and be linked to an auto dial or similar facility to alert the staff to non-conformities outside normal working hours. The center should have adequate staff and funding for an on-call system for responding to alarms out of working hours and adequate spare storage capacity to enable transfer of samples when required. Every ART clinic and ART bank shall allow inspection of the place, equipment and records to the national board, national registry, state board or appropriate authority or any officer authorized on this behalf.
The ART bank the minimum staff requirements are a registered medical practitioner trained in preparation and storage of semen sample and also a counselor. So, the duties of the clinics and bank this is a pictorial representation that is the step 1 is the preparatory phase where the clinic should confirm and eligibility of the commissioning couple are these couple who have come for treatment are they eligible that should be confirmed. Then the gametes should be tested for the prescribed diseases, the commissioning couple to be counseled about the success of ART and all complications as well as cost of procedure and the commissioning couple must be aware of the rights of a child born through the use of ART.
Detailed records of donor's oocyte, sperm or embryo used or unused, the manner and technique of their use should also be maintained. Now in the step 2 when they are going to retrieve the egg from the ovaries, not more than 3 oocytes or embryos may be placed in the uterus of a woman and this woman shall not be treated with gametes or embryos derived from more than one man or woman during any one treatment cycle and never make semen from two individuals and the embryo shall not be split and used for twinning to increase the number of available embryos and the collection of gametes posthumously shall be done only if prior consent of the commissioning couple is available. Now the third step that is fertilization of eggs, the pre-implantation genetic testing shall be used to screen the human embryo for known pre-existing heritable or genetic diseases only that means no sex selection.
All unused oocytes shall be preserved by the banks for use on the same recipient or may be given for research. The fourth step that is fertilization of eggs, embryoculture and embryo transfer, the gamete of a donor or embryo shall be stored for a period of not more than 10 years. The sale, transfer or use of gametes, zygotes and embryos directly or indirectly to any party within or outside India shall be prohibited.
And finally, pregnancy. The child born through assisted reproductive technology shall be deemed to be a biological child of the commissioning couple and the said child shall be entitled to all the rights and privileges available to a natural child. However, a donor shall relinquish all parental rights over the child or children which may be born from his or her gamete.
The person shall not sell human embryo or gamete, run an agency, a racket or an organization for selling, purchasing or trading in human embryos or gametes. The person shall not import or help in getting imported in whatsoever manner the human embryos or human gametes. The person shall not exploit the commissioning couple, woman or the gamete donor in any form.
The person shall not transfer human embryos into a male person or an animal. The person shall not sell any human embryo or gamete for the purpose of research. And finally, the person shall not use any intermediates to gain gamete donors or purchase gamete donors.
So, let us now look at the demerits of this ART law. While the Act is very decisive and a considerable step towards curbing the menace of illegal and unregulated ARTs and towards safeguarding donors and women undergoing ART from the health implications faced due to unsafe and illegal procedures, it falls short of addressing some serious concerns. First and foremost, the Act excludes unmarried men, divorced men, widowed men, unmarried yet cohabiting heterosexual couples, trans persons and homosexual couple whether they are married or cohabiting from availing ART services.
To sum it up, the gynecologist should know what she is doing and how to go about investigating and managing cases of infertility. Competence in gynecological ultrasound to diagnose reproductive tract anomalies, monitor ovarian and uterine response to stimulation, picking up oocytes at their most appropriate time and embryo transfer by any one of the several methods currently available to handle embryo transfers in difficult cases. The gynecologist must be knowledgeable about the principles of ovarian stimulation and management of complications like OHSS.
The responsibility of gynecologist will also include interviewing the infertile couple initially, history taking, physical examination of the female, recommending appropriate tests to be carried out, interpreting them and treating medical disorders such as infection and endocrine anomalies, carrying out gynecological endoscopy and ultrasonic intervention for diagnosis and therapy of infertility, and carrying out ART procedures and other ancillary procedures as the case and facilities may warrant based on diagnostic evidence. The ART specialist should do self-appraisal and maintain records for audit. The Andrologist The qualifications of the andrologist.
The andrologist must understand the principles of semen analysis and their values and limitations in the diagnosis of male fertility status. The andrologist must be able to collect semen by prostatic massage for microbial culture in cases where infection may lie in the upper regions like the prostate and or the semiannual vesicles of the reproductive tract. The andrologist should also be able to collect spermatozoa through surgical sperm retrieval techniques and be well versed in the technique of electro ejaculation.
The andrologist must also be knowledgeable about the implications of using poor quality sperm for ICSI. The andrologist should be familiar with the surgical procedures available for correcting an anatomical defect in the reproductive system such as epididymal, vasal, re-anastomosis and varicose electomy.
When it comes to experience, knowledge, manner of instruction, and affiliation with IVF courses, Medline Academics is among the rarest institutions offering a Fellowship in Reproductive Medicine in India. Institutions that offer training courses now act as a springboard for IVF specialty services. Hospitals and academies that are in operation provide courses that comply with ART criteria. A handful of them have only recently begun their training in Fellowship in Reproductive Medicine in Bangalore. Spanning over 4 decades of teaching excellence, Medline Academics prides itself on 1000s of candidates trained in infertility, embryology, ultrasound, and endoscopy who have now established themselves in their respective fields. Medline Academics is committed to bringing in a learning revolution with an e-learning platform that enables learning with no compromise on professional practice. To know about the IVF Course Fees, please visit our website or our centre in Bangalore.
IVF Hospital in Bangalore - Dr. Kamini Rao Hospitals, is a unit of Medline Academics. The university allows its students to watch the best cases and, in certain situations, even handle the cases with professional supervision in addition to the standard course format. This hospital, which is in the center of the city, is always full with patients who come with optimism, and the pioneer Padma Shri Prof. Dr. Kamini A Rao and her skilled team of medical professionals grant their desires. This institution serves as a therapeutic center in addition to a place of education.