Metformin treatment before IVF/ICSI in normal weight women with polycystic ovarian syndrome. A Europeah, prospective, randomised, double blind, multicenter study. - MET-AR study. Metformin in assisted reproduction.

Conditions: Polycystic ovary syndrome (PCOS) is a disorder characterized by polycystic ovaries, oligo-amenorrhea and hyperandrogenism. It is the most common endocrine disorder in women of fertile age. PCOS women are an-or oligoovulatory and often suffer from infertility or subfertility. Prevalence estimates vary between three and twenty persent depending on the diagnostic criteria used and the population studied. A prevalence of five to seven percent has been reported in Caucasian women.

Registration Number: EUCTR2004-001124-20-GB

Lead Sponsor: Sigrun Kjotrod

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

•Infertile (> 1 year) PCOS-women planned for treatment with IVF/ICSI
•First or second cycle of IVF/ICSI - treatment
•Age < 38 years at inclusion
•BMI < 28 kg/m² at inclusion
•Patient willing to be randomised to 4 months treatment with metformin or placebo
•Patient has given written informed consent
•If previously on metformin, a one-month washout period is required before inclusion.
•PCOS –diagnosis based on the Rotterdam revised criteria 2003 / ESHRE-ASRM criteria – fulfilling at least two out of the following three criteria:
1.Oligo-amenorrea.
2.Hyperandrogenism
3.Polycystic ovaries by ultrasound

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

More than one previous IVF cycle
Patients not suitable for starting dose 112,5 IE Gonal-F
Basal s-FSH more than 10 IU/L
Known liver disease, or s-ALAT > 80 IU/l
Known renal disease, or s-kreatinin > 130 mmol/l
Known alcoholism or drug abuse
Known diabetes mellitus or fasting plasma glucose =6.7 mmol/L
Per oral steroid hormone treatment
Treatment with cimetidin, anticoagulantia, erythromycin, or other macrolides.
Hyperprolactinemia (s-Prolactin > 700 mIE/L)
Abnormal thyroid function tests
Congenital adrenal hyperplasia
Androgen secreting tumors
Cushing’s syndrome
Unfit to participate of any other reason