Overweight or obese women with polycystic ovary syndrome (PCOS) and infertility may be more likely to get pregnant if they lose weight before beginning infertility treatment, a secondary analysis of data from two multicenter randomized trials suggests.
Richard S. Legro, MD, from Penn State College of Medicine, Hershey, Pennsylvania, and colleagues describe their findings in an article published online May 12 in the Journal of Clinical Endocrinology and Metabolism.
"[P]retreatment lifestyle modification for weight loss, with or without concurrent [oral contraceptive (OCP)] therapy, was associated with a significant improvement in the rate of ovulation and an even greater increase in live birth rate than immediate fertility treatment with clomiphene," the researchers write.
Among those who received immediate treatment with clomiphene alone, the ovulation rate was 44.7% (277/619), and the live birth rate was 10.2% (19/187). Among the women who received clomiphene after the lifestyle modification program, the ovulation rate was 62.0% (80/129), and the live birth rate was 25.0% (12/48).
Compared with those who received immediate clomiphene treatment, the women who participated in lifestyle modification with or without OCP before clomiphene treatment had a 2.5-fold (P = .01) increase in live births They also showed a 1.4-fold increase in cumulative ovulation rate compared with those who received immediate clomiphene treatment.
The lifestyle modification group was the only group with a significantly improved likelihood of pregnancy and live birth in the first ovulation induction cycle compared with the first ovulation induction cycle in the group that received immediate clomiphene.
The risk for pregnancy loss was no different for those who received immediate clomiphene treatment compared with those who received pretreatment OCP, lifestyle modification, or both.
"Our research holds significant implications for current practice, and supports the concept of delaying fertility treatment to pursue lifestyle modification in overweight/obese women with PCOS. It provides momentum to test this concept more completely and prospectively in properly designed and adequately powered multicenter studies to generate Level I evidence for the practice," the authors explain.
Secondary Analysis of Data From Two Studies
The two trials included in the new analysis are the Treatment of Hyperandrogenism vs Insulin Resistance in Infertile PCOS Women (OWLPCOS study) and the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II study); the researchers conducted them concurrently.
The OWLPCOS study was an open-label, two-site study in which researchers randomly assigned 149 women to receive one of following treatments before beginning clomiphene: continuous OCPs, a 16-week lifestyle modification program aimed at weight loss and increased physical activity, or both. The study showed a trend toward increased live birth in the lifestyle modification group compared with the OCP and combined groups, but the study was underpowered to address this outcome. The investigators included 142 women from this trial in the new analysis.
The PPCOS II study was a multicenter trial that compared immediate clomiphene to immediate letrozole. The researchers randomly assigned 750 women to immediate ovulation induction with either clomiphene or letrozole. The researchers included 187 women from the clomiphene group (n = 376) in the new analysis.
"Future studies may also want to utilize other ovulation induction agents in the infertility treatment phase such as low dose gonadotropin or letrozole, which tend to have greater success rates combined with comparable rates of multiple pregnancy and congenital anomalies as clomiphene," the authors conclude.
In addition, the authors note that the current analysis did not show any substantial differences in outcomes among women with OCPs compared with immediate fertility treatment, "suggesting that there is little fertility benefit to pretreatment with hormonal suppression, alone or in combination with lifestyle modification," the researchers write.
Dr Legro reports consulting fees from Euroscreen, AstraZeneca, Clarus Therapeutics, Takeda, and Kindex, and research funding from Ferring and AstraZeneca. Two authors report research funding from AbbVie. One author reports consulting fees from JDS Therapeutics. One author reports ownership of Merck stock. One author reports consulting fees from BAROnova, EnteroMedics, and Ethicon. The other authors have disclosed no relevant financial relationships.
J Clin Endocrinol Metabol. Published online May 12, 2016. Full text
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Cite this: PCOS: Weight Loss Before Fertility Treatment Ups Birth Rates - Medscape - May 24, 2016.
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