Leading fertility specialists in India have issued a strong advisory for caution regarding the immediate clinical application of a new, non-invasive method for genetic screening of embryos. The technique, known as non-invasive preimplantation genetic testing (niPGT), analyzes genetic material from the embryo's culture medium rather than directly from the embryo cells themselves.
What is niPGT and Why the Concern?
The conventional method for preimplantation genetic testing, PGT, requires a biopsy where a few cells are removed from the embryo for analysis. This invasive procedure, while established, carries a small risk of harming the embryo. The proposed niPGT method offers a tantalizing alternative by testing the cell-free DNA shed by the embryo into the culture fluid, eliminating the need for direct biopsy.
However, experts from the Indian Society of Assisted Reproduction (ISAR) and the Preimplantation Genetic Diagnosis Society of India (PGDIS) have raised significant red flags. In a recent consensus statement, they highlighted that the scientific evidence for niPGT's accuracy and reliability is not yet robust enough for routine clinical use. The primary concern is the high risk of false-positive and false-negative results, which could lead to the wrongful transfer of embryos with genetic abnormalities or the discarding of healthy, viable embryos.
Key Recommendations from the Expert Bodies
The consensus, developed by a committee including prominent figures like Dr. Himanshu Bavishi, President of ISAR, and Dr. Sulbha Arora, Clinical Director of Nova IVF Fertility, outlines clear guidelines. They strongly recommend that niPGT should currently be used only within the confines of a research setting with proper ethical approval and informed consent from patients.
The experts have laid down several critical conditions for any future clinical adoption. These include the need for extensive validation studies specific to Indian population genetics and the IVF culture media and protocols used in Indian clinics. They insist that any clinic offering niPGT must also have the infrastructure and expertise for standard, invasive PGT as a necessary backup to confirm results before making crucial decisions about embryo transfer.
A Call for Standardization and Rigor
A major point of contention is the lack of standardization. Different companies may use varying methods to analyze the cell-free DNA, leading to inconsistent results. The consensus stresses that without standardized, validated protocols, introducing niPGT into clinical practice is premature and potentially dangerous for patient outcomes.
The societies have made it clear that they do not endorse the use of niPGT as a standalone diagnostic tool at this stage. Their stance is a protective measure for patients undergoing the emotionally and financially taxing process of IVF. The goal is to prevent the misuse of a promising but unproven technology that could compromise a couple's chances of achieving a successful pregnancy.
In conclusion, while acknowledging the potential future benefits of non-invasive genetic screening, the Indian fertility community has taken a prudent, evidence-based stand. They advocate for patience, rigorous science, and robust local validation before this new test can be trusted with the profound responsibility of selecting embryos for implantation. The well-being of prospective parents and their future children remains the paramount concern.
