Healthcare (Commonwealth Union) – As fertility rates across the globe that well below the replacement level, measures such as In Vitro Fertilization (IVF) become essential. In a global review led by University of Sydney in Australia found that a hormone treatment frequently marketed worldwide as an IVF “add-on” does not increase the likelihood of pregnancy.
The research, published in Human Reproduction Update, concluded that giving the hormone human chorionic gonadotropin (hCG) inside the uterus before embryo transfer fails to improve pregnancy or live birth outcomes.
The treatment is widely used in countries including Australia, the United States, Europe, and parts of Asia. Since the early 2010s, it has been promoted as a way to boost embryo implantation during IVF, largely because earlier studies suggested it had beneficial effects.
But after examining the original raw data from those studies instead of relying only on the published findings, researchers discovered that the reported benefits of the hormone treatment were not supported by the evidence.
Dr Rui Wang, who is the lead author and Academic Lead of Evidence Integration Group at the NHMRC Clinical Trials Centre indicated that for patients and clinicians, there is a straight forward message that this add-on is unable to enhance fertility outcomes.
He further pointed out that the hormone must not be routinely provided as a component of IVF treatment.
Rather than depending on previously published findings from clinical trials, the researchers carried out an individual participant data meta-analysis. This approach involved gathering and reassessing raw, anonymised information from every patient who took part in all relevant clinical trials on the subject.
New analytical tools in recent years has made data analysis more sophisticated in comparison to many years back.
Among 28 randomised studies carried out in several countries — including the United States, Austria, Thailand and Japan — examining the use of intrauterine hCG before embryo transfer, seven high-quality trials involving 2,244 IVF patients satisfied the requirements for inclusion in the analysis.
The team discovered that the treatment did not increase live birth rates or clinical pregnancy rates, with the same outcome observed across every patient subgroup assessed.
Dr Wang pointed out that there was no sign of benefit in any category we examined, whether involving fresh or frozen embryo transfers, varying embryo stages, or different dosage levels.
Previous reviews had identified intrauterine hCG as one of the most promising add-on treatments in IVF, with studies reporting notable improvements in pregnancy rates. Those findings were widely referenced and helped shape clinical practice.
However, Dr Wang said many of the trials that reported positive outcomes did not meet basic standards for data reliability and trustworthiness.
He indicated that once they limited the analysis to studies where the raw data could be independently reviewed and verified, the apparent benefit disappeared entirely.
The researchers of the study indicated that the findings add to growing concerns over the quality and reliability of clinical trial data in women’s health research, particularly in fields where findings are quickly adopted into medical practice.
“Every procedure offered to patients should be backed by reliable evidence,” explained Dr Wang. “When patients are already going through multiple IVF cycles, adding procedures with no proven benefit is an unnecessary burden on people navigating an already difficult journey.”
The researchers said the results could reflect a broader issue in reproductive medicine, where some IVF treatments and add-ons are introduced into clinical practice on the basis of weak or unreliable evidence.
Dr Wang said many IVF add-ons initially appear effective because early studies often report positive outcomes. However, he warned that if those studies are poorly designed or the underlying data cannot be independently verified, patients may be making decisions based on evidence that ultimately fails to stand up to scrutiny.
