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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oulu
• Collaborators: Helsinki University; Tampere University; University of Eastern Finland; University of Helsinki; University of Tampere; University of Turku
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. age < 40 years at entry

2. BMI > 19 kg/m2

3. Infertility lasting > 1 year

4. 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 Criteria:

1. diabetic subjects

2. alcohol users

3. active liver disease (ALAT > +2 SD the upper normal value i.e.> 100IU/l)

4. hormonal drugs

5. past or present cardiac failure (NYHA I-IV)

6. liver or renal failure (S-Creatinine above the normal value ie.124 umol/l)

7. pregnancy or lactation

8. hypersensitivity to metformin