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Treatment with prednisone did not improve live birth rates among women with recurrent implantation failure compared with placebo, a randomized trial from China showed.

Of over 700 women included in the intention-to-treat analysis, 37.8% of those who received 10 mg of prednisone had a live birth versus 38.8% of those who received placebo (relative ratio [RR] 0.97, 95% CI 0.81-1.17, P=0.78), reported Yun Sun, MD, PhD, of Shanghai Jiao Tong University, and colleagues.

Furthermore, "there were no statistically significant between-group differences in the rates of biochemical pregnancy, clinical pregnancy, implantation, neonatal complications, congenital anomalies, other adverse events, or mean birthweights," they wrote in .

Biochemical pregnancy loss occurred in 17.3% of the prednisone group and 9.9% of the placebo group (RR 1.75, 95% CI 1.03-2.99, P=0.04), while preterm delivery occurred among 11.8% and 5.5%, respectively (RR 2.14, 95% CI 1.00-4.58, P=0.04).

"Given the possible additional risk of preterm delivery and biochemical pregnancy loss along with its administration, these data results do not support the routine use of 10 mg of prednisone for the treatment of recurrent implantation failure," Sun and team concluded.

Despite a lack of high-quality evidence, prednisone is often used to improve the chance of implantation and pregnancy, according to the study.

Sun's group noted that 50% to 60% of in vitro fertilization (IVF) cycles do not result in a successful implantation. Recurrent implantation failure "is a commonly encountered condition among patients undergoing IVF, which causes great distress and frustration to both patients and clinicians," they wrote. "As a result, clinicians may be tempted or feel pressure to 'do something different' after two or more unsuccessful embryo transfer cycles."

Rachel Weinerman, MD, of Case Western Reserve University in Cleveland, who was not involved with the study, told 番茄社区app that there's a lot that doctors don't know when it comes to why IVF doesn't always work.

"Prednisone is a very powerful immunomodulator and it can help dampen down the body's immune response, especially to autoimmune diseases," she explained. "This study confirms what we already knew, but it confirms it with good-quality evidence."

Sun and colleagues noted that because only women with good-quality embryos were recruited for this study, "we should be cautious to extrapolate these results to women with less favorable prognosis."

Weinerman also pointed out that certain groups were left out of this study by design -- and their results may be different.

"I would say the bigger question in my mind is that they also excluded patients who have a history of immunodeficiencies or known autoimmune diseases. We don't know why somebody might not be able to get pregnant or why their transfers are not working. But it's possible that patients that have autoimmune issues may be the ones that most benefit from prednisone during their transplant. So you may be eliminating patients who would benefit with your trial design," she said.

She also added that future studies specifically looking at outcomes for women with autoimmune diseases or recurrent pregnancy loss would be valuable.

When applying these results to the U.S., Weinerman said that it is important to consider that women in the U.S. have different profiles than Chinese women, and U.S. clinicians have slightly different protocols for frozen transfers. Ultimately, she said that these factors would likely not have a major impact on the findings.

"I think that this study is an important reminder that we should think carefully before using treatments that do not have a lot of evidence, as it's possible that they could introduce harm," Weinerman added.

For this double-blind trial, participants were recruited from eight academic fertility centers across China from November 2018 to August 2020. Eligible women were younger than 38, had two or more unsuccessful embryo transfer cycles, and had plans to undergo a frozen-thawed embryo transfer with good-quality embryos.

A total of 715 participants (mean age 32) were randomized in a 1:1 ratio to 10 mg of prednisone or placebo, and 714 had data on live birth outcomes and were included in the primary analysis.

While the frequency of singleton live births was similar between groups, the frequency of twin live birth rates were 4.2% in the prednisone group and 1.7% in the placebo group (RR 2.51, 95% CI 0.98-6.39, P=0.05).

No between-group differences in live birth rates were seen for women with cleavage or blastocyst transfers or among those with two, three, four, five or more previous failed embryo transfer cycles.

Sun and team noted that their results may not be applicable to patients receiving other prednisone doses or regimens. Furthermore, the observed live birth rate was higher than expected in both groups, which may have been partly due to the use of frozen-thawed embryo transfer.

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