Status:
COMPLETED
The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
University of Oulu
Collaborating Sponsors:
University of Eastern Finland
University of Helsinki
Conditions:
Polycystic Ovary Syndrome
Miscarriage
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief 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 wom...
Detailed Description
Women with PCOS represent about 5-10% of the general female population and one third of the women treated for infertility. Thus, the development of new therapies to improve the efficiency of ovulation...
Eligibility Criteria
Inclusion
- age \< 40 years at entry
- BMI \> 19 kg/m2
- Infertility lasting \> 1 year
- Criteria for PCOS are as defined by ESHRE/ASRM: at least two of the following findings:
- polycystic ovaries shown by vaginal ultrasonography (more than 12 subcapsular follicles of 3-8 mm diameter in one plane of the ovary)
- oligomenorrhea or amenorrhea
- clinical manifestations of hyperandrogenism such as a hirsutism score of \> 7 according to Ferriman and Gallwey (Ferriman \& Gallwey 1961)and/or an elevated serum testosterone level (\> 2.7 nmol/l).
Exclusion
- diabetic subjects
- alcohol users
- active liver disease (ALAT \> +2 SD the upper normal value i.e.\> 100IU/l)
- hormonal drugs
- past or present cardiac failure (NYHA I-IV)
- liver or renal failure (S-Creatinine above the normal value ie.124 umol/l)
- pregnancy or lactation
- hypersensitivity to metformin
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00994812
Start Date
August 1 2002
End Date
December 1 2009
Last Update
February 23 2010
Active Locations (5)
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1
University Hospital Of Helsinki
Helsinki, Finland
2
University Hospital of Kuopio
Kuopio, Finland
3
University Hopsital of Oulu
Oulu, Finland, 90029
4
University Hospital of Tampere
Tampere, Finland