drugset / Trial / NCT01233206

Metformin in High Responder Polycystic Ovary Syndrome (PCOS) Patients Undergoing IVF Cycles

NCT01233206 ↗

Phase 4 Completed 120 enrolled University Magna Graecia
RandomizedParallel-groupTriple-blindTreatment

Summary

The use of metformin pre-treatment and co-administration was recently proposed in infertile women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins. Data from meta-analyses showed that metformin administration significantly reduced the stimulation length and the total dose of gonadotropins used in PCOS women undergoing gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins. The metformin regulating effect on the ovarian response was also observed in a randomized controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving gonadotropins for mono-ovulation induction. In particular, metformin increased the mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used, while it reduced the number of dominant follicles and the estradiol (E2) levels. The aim of the present study was to evaluate the effect of metformin administration in high responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.

Timeline

Start
2009-05
Primary completion
2010-11
Completion
2011-01

Outcome

Met primary endpoint

paper The total OHSS and cancellation rates were significantly reduced in patients treated with metformin. PMID 21982727 ↗

paper The relative risk for OHSS was of 0.28 (95% confidence interval, 0.11-0.67). PMID 21982727 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg —