NCT00159575

Metformin in Assisted Reproduction-MET-AR-study

Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

Summary

Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index \[BMI\] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.

Detailed description

PCOS is an hormonal disease including hyperandrogenism, oligo-or anovulation and/or polycystic ovaries by ultrasound. PCOS women often suffer insulin resistance or even diabetes risk as well as a full blown metabolic disease. These women often suffer infertility due to their lack of regular ovulations. Metformin is a well known anti-diabetic drug, and in some PCOS women metformin might decrease the hyperandrogenism, improve insulin resistance and give more regular ovulations. Thereby increase chance of pregnancy. Our hypothesis is that metformin will increase clinical pregnancy rates both spontaneously and following IVF/ICSI.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Metformin / Placebo treatment for 4 months	M: Metformin 2000mg daily- 12-14 weeks of pretreatment + metformin 2000mg daily through conventional IVF ending on the day of pregnancy test; IE. 14 days after embryo transfer. P: Or identical placebo treatment for the same period

Timeline

• Start date: 2005-03-01
• Primary completion: 2009-08-01
• Completion: 2010-04-01
• First posted: 2005-09-12
• Last updated: 2012-01-05

Locations

2 sites across 1 country: Norway