The rise in assisted reproduction procedures means more Indian couples are seeking ways to build families. The technique known as non-invasive preimplantation genetic testing (niPGT) has recently emerged as a popular option. However, the country’s leading fertility and embryology bodies have strongly cautioned against the routine niPGT clinical use. In a joint position statement, the Indian Society for Assisted Reproduction (ISAR), the Indian Fertility Society (IFS), and the Academy of Clinical Embryologists (ACE) flagged the test, citing high misdiagnosis rates and a lack of convincing evidence for its efficacy. Consequently, they urge clinics not to use niPGT for deciding which embryos to transfer.
Understanding niPGT vs. Conventional PGT-A
Conventional preimplantation genetic testing (PGT-A) involves removing a few cells from the embryo’s outer layer, which is a technically demanding procedure. PGT-A aims to test embryos for chromosomal abnormalities, but it can raise concerns about embryo safety. In contrast, niPGT—also known as non-invasive chromosomal screening (NICS)—analyzes tiny fragments of DNA that embryos naturally release into the culture medium. As a result, commercial laboratories often promote niPGT as a safer, non-invasive, and easier-to-perform alternative. Therefore, its uptake among clinics and patients in India has steadily increased.
niPGT Clinical Use: The Problem with Diagnostic Accuracy
Despite its promise, considerable uncertainty exists in the scientific community regarding niPGT’s accuracy. The joint review by the ISAR, IFS, and ACE analyzed 24 published studies, comparing niPGT results for nearly 3,000 embryos against the standard biopsy-based testing. They found that niPGT matched conventional testing only about 78 per cent of the time. This means that approximately one in five embryos may be misclassified, which raises serious concerns about reliability. In fact, genetically normal embryos could be wrongly labeled as abnormal and discarded. Furthermore, abnormal embryos might be incorrectly labeled as normal and subsequently transferred, increasing the risk of miscarriage or chromosomal disorders. Therefore, the significant error rates, including unacceptably high false positives and false negatives, undermine niPGT’s reliability for clinical decision-making.
Clinical Efficacy and Embryo Selection Warnings
Leading experts determined there is no convincing evidence that niPGT actually improves clinical outcomes. Specifically, there is no proof it improves implantation rates, pregnancy rates, or live birth rates. Moreover, many niPGT protocols necessitate six days of embryo culture, a practice independently linked to poorer outcomes in large studies. Because IVF treatment is largely patient-funded in India, add-on tests must be reliable, validated, and genuinely beneficial. Consequently, the societies stressed that niPGT should not currently be used to select, rank, or discard embryos. Instead, the technology should continue to be explored strictly within ethically approved research settings. Eventually, the guidance will be reviewed and updated as stronger evidence emerges. In conclusion, the current consensus is that the technology does not yet meet the diagnostic standards required for determining an embryo’s fate. For professionals looking to master the complex field of assisted reproduction, continued education is key, such as pursuing an International Post Graduate Program In Assisted Reproduction Techniques.
Frequently Asked Questions
Q1: What is niPGT and how does it differ from traditional PGT-A?
niPGT (Non-Invasive Preimplantation Genetic Testing) analyzes cell-free DNA fragments that an embryo naturally releases into its culture medium. This contrasts with traditional PGT-A (Preimplantation Genetic Testing for Aneuploidy), which requires an invasive biopsy to remove a few cells from the embryo’s outer layer for genetic testing.
Q2: Why did ISAR, IFS, and ACE advise against the routine clinical use of niPGT?
The three leading Indian societies advised against routine clinical use due to two main reasons: high diagnostic inaccuracy (about 22% misclassification rate) and a lack of conclusive evidence that niPGT improves clinical outcomes, such as live birth rates. Therefore, they argue that the test is not yet reliable enough for clinical decision-making.
Q3: What are the primary risks associated with using niPGT for embryo selection?
The primary risk is misclassification. Due to its high error rate, a genetically normal embryo might be falsely labeled as abnormal and wrongly discarded (false positive). Conversely, an abnormal embryo could be incorrectly labeled as normal and transferred (false negative), which increases the risk of miscarriage or chromosomal disorders.
References
- Indian fertility experts advise caution on clinical use of new ‘Non-Invasive’Embryo Genetic Test – ETHealthworld.
- Joint Position Statement on The Clinical Use of Non-Invasive Preimplantation Genetic Testing (niPGT) by Indian Assisted Reproduction Societies. isarindia.net.
- Evaluation of the Effectiveness and Accuracy of Non-Invasive Preimplantation Genetic Testing (niPGT) Compared to Invasive Embryo Biopsy. ResearchGate.
- Evaluation of the Effectiveness and Accuracy of Non-Invasive Preimplantation Genetic Testing (niPGT) Compared to Invasive Embryo Biopsy. NIH.
- Non-invasive preimplantation genetic testing for aneuploidy: is the promise real? PubMed.
- Clinical Use of Non-Invasive Preimplantation Genetic Testing – A Joint Position Statement from the Indian Society for Assisted Reproduction, Indian Fertility Society and Academy of Clinical Embryologists. ResearchGate.
- The impact of implementing a non-invasive preimplantation genetic testing for aneuploidies (niPGT-A) embryo culture protocol on embryo viability and clinical outcomes. ResearchGate.
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