The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS)

PHASE3CompletedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Polycystic Ovary SyndromeMiscarriageInfertilityToxemiaGestational Diabetes
Interventions
DRUG

metformin

The obese women will be randomized either to metformin (2g/day) or to placebo, and the non-obese either to metformin (1.5g/day) or to placebo. All subjects will be evaluated 1 to 7 days after spontaneous menstruation (oligomenorrheic patients), or at any other convenient time (amenorrheic subjects). After the treatment of 3 months with metformin/placebo alone, another appropriate infertility treatment will be combined with metformin/placebo (clomiphene, ovulation induction, insemination or in vitro fertilization) if no pregnancy has occurred. This treatment will be continued another 6 months' period. If pregnancy occurs, subjects will be re-examined at 7-8 weeks of gestation.

Trial Locations (5)

90029

University Hopsital of Oulu, Oulu

Unknown

University Hospital Of Helsinki, Helsinki

University Hospital of Kuopio, Kuopio

University Hospital of Tampere, Tampere

University Hospital of Turku, Turku

All Listed Sponsors
collaborator

University of Eastern Finland

OTHER

collaborator

University of Helsinki

OTHER

collaborator

Tampere University

OTHER

collaborator

University of Turku

OTHER

lead

University of Oulu

OTHER

NCT00994812 - The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS) | Biotech Hunter | Biotech Hunter