Govt tightens norms for IVF procedures

The government has told IVF clinics to follow compliance procedures with respect to the retrieval of oocytes (a developing egg in a female), limiting the number of oocytes in one cycle, and putting a cap on the number of embryos that can be transferred to the female during the treatment cycle.

The government also reminded clinics that procedures should be conducted in females of advanced maternal age and those who have faced recurrent miscarriages.

The tightening of regulations will have an impact on the mushrooming IVF industry and help rein in unnecessary procedures undertaken by clinics just to make money.

The ministry also regulated the procedure for embryo transfer in the uterus.

The Assisted Reproductive Technology Regulations, 2023 mention that a gynaecologist should transfer 1-2 embryos in the uterus during a treatment cycle depending upon the medical condition of the patient.

Only in exceptional circumstances—such as advanced maternal age, recurrent miscarriages and recurrent implantation failure—can three embryos be transferred. In any case, the doctor cannot transfer more than three embryos.

Welcoming the government’s move, Dr Archana Dhawan Bajaj, an IVF expert at Nurture Clinic in New Delhi, said, “This initiative will bring more transparency and offer clear cut guidelines to the doctors in terms of what they can and cannot do. It will ensure patient safety. Now that the government has limited the number of embryo transfers, i.e., 1-2 in a cycle and in rare cases 3 embryos, the biggest advantage of this capping is that it will prevent multiple births like triplets or quadruplets.”

Besides this, it will decrease morbidity in the newborns and thus, reduce the pressure on the healthcare system.

Experts said many IVF clinics across the country operate with semi-trained staff and no expertise in the field that put patients’ lives at risk. Hence, such regulations are required from time to time to regulate the industry.

The government notification said clinics shall retrieve oocytes from the donor after the consent of the donor and for retrieving oocytes from the donor, clinics shall make efforts to retrieve not more than seven oocytes during one cycle.

Further, the notification said clinics shall retrieve all formed follicles and ensure controlled ovarian stimulation of woman to prevent ovarian hyperstimulation.

Many couples with infertility issues opt for IVF. India has as many as 27.5 million infertile people, according to the Indian Society of Assisted Reproduction.

“For the welfare of the donor, there must be a health insurance for her, and we must make sure that one donor is not being repeated and has given her consent for the same. Because you cannot control the number of eggs that get stimulated, retrieving seven oocytes from a person who is hyper stimulated can increase the donor’s morbidity. For instance, if a donor has PCOD (Polycystic Ovarian Disease), then she will have many follicles and if we do not retrieve all the follicles then she stands at the risk of ovarian hyperstimulation which can increase the risk of morbidity. So, in selected donors where higher number of follicles are stimulated, capping of seven oocytes during one cycle may be a little worrisome,” Dr Bajaj said.

Queries sent to the health ministry remained answered.