ART Regulations 2023: Why Restriction On Transfer Of Embryos Is Needed?

Starting April 4, 2023, the Assisted Reproductive Technology Regulations 2023 has become effective. The Ministry of Health and Family Welfare has tightened the norms for vitro fertilization (IVF) procedures with an aim to regulate the mushrooming IVF industry, curb unnecessary procedures undertaken by clinics just to make money and ensure the safety of patients undergoing fertility treatments.

The government has limited the number of embryos that can be transferred to the female during the treatment cycle. Under the new regulations, a gynaecologist is allowed to transfer only 1-2 embryos in the uterus during a treatment cycle, depending upon the medical condition of the patient. Transfer of three embryos is allowed only in exceptional cases, such as advanced maternal age, recurrent miscarriages, and recurrent implantation failure. However, transfer of more than three embryos is not allowed in any case.

“The restriction on the transfer of embryos as part of the ART Act is a welcome move and much needed. This is typically done to promote the health and safety of both the mother and the baby, while still maximizing the chances of a successful pregnancy,” says Dr. Sulbha Arora, Clinical Director, Nova IVF Fertility, Mumbai.

What are the risks associated with transfer of more than one embryo?

The restriction on the transfer of embryos is expected to prevent multiple births like triplets or quadruplets and decrease morbidity in newborns.

Dr. Sulbha expounds, “Multiple pregnancies resulting from the transfer of more than one embryo may increase the risk of premature delivery, low birth weight, and other complications for both the mother and the babies. These complications can lead to long-term health problems for babies, including developmental delays and disabilities.”

Transferring multiple embryos can increase the risk of ovarian hyperstimulation syndrome (OHSS), which can cause abdominal pain, bloating, and other symptoms.

According to Dr. Sulbha, OHSS is a potentially life-threatening condition that can occur when the ovaries over-respond to fertility medications, causing fluid to accumulate in the abdomen and chest.

“Ectopic pregnancy, where the fertilized egg implants outside of the uterus, usually in the fallopian tube, is another risk associated with transferring more than one embryo. Ectopic pregnancy is a medical emergency that requires immediate treatment,” she adds.

How can clinics avoid multiple embryo transfer and achieve successful IVF outcomes?

Given the risks associated with multiple embryo transfer, the ideal outcome of IVF is a single healthy baby, which can only be achieved by transferring one healthy embryo at a time, asserts Dr. Sulbha.

She adds, “In order to select the best embryo for transfer and minimise the number of embryos being transferred, it’s important that the embryo transfer be done at the blastocyst stage, as many embryos may grow upto earlier stages of development, but inherently weak or abnormal embryos often don’t make it to the blastocyst stage, giving a natural selection of the best to transfer.”

Restriction on retrieval of oocytes

Under the Assisted Reproductive Technology Regulations 2023, the government has also imposed restriction on the retrieval of oocytes (developing eggs in a female). As per the new regulations, the donor’s consent is important before retrieving oocytes, and not more than seven oocytes should be retrieved during one cycle. Further, the IVF clinics are told to retrieve all formed follicles and ensure controlled ovarian stimulation of the woman to prevent ovarian hyperstimulation.

 

 

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