MedTrace Logo

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

NCT00994812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2010-02-23

No results posted yet for this study

Summary

The purpose of this study is to determine whether metformin may improve pregnancy rates, and decrease miscarriage rates and complications of pregnancy, such as toxemia and gestational diabetes, in women with polycystic ovary syndrome (PCOS).

Conditions

  • Polycystic Ovary Syndrome
  • Miscarriage
  • Infertility
  • Toxemia
  • Gestational 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.

Sponsors & Collaborators

  • University of Eastern Finland

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • Tampere University

    collaborator OTHER

  • University of Turku

    collaborator OTHER

  • University of Oulu

    lead OTHER

Principal Investigators

  • Laure C Morin-Papunen, PhD · University hospital of Oulu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00994812 on ClinicalTrials.gov