NCT00795808

PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: University of Auckland, New Zealand · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

1. Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS). 2. Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI \</= 32). 3. Metformin improves fertility outcomes in women with BMI \> 32 with PCOS.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Metformin	500mg tds for 6 months
DRUG	Placebo	One tablet tds for 6 months
DRUG	Metformin + Clomiphene	500mg tds + Ovulatory dose for 6 months
DRUG	Metformin	500mg tds for 6 months
DRUG	Clomiphene	Ovulatory dose for 6 months

Timeline

• Start date: 2003-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-11-21
• Last updated: 2008-11-21

Locations

1 site across 1 country: New Zealand