Metformin in Assisted Reproduction-MET-AR-study

Polycystic Ovary Syndrome Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

• NCT number: NCT00159575
• Study type: Interventional
• Source: Norwegian University of Science and Technology
• Status: Terminated
• Phase: Phase 4
• Start date: March 2005
• Completion date: April 2010