Metformin treatment before IVF/ICSI in normal weight women with polycystic ovarian syndrome. A European, prospective, randomised, double blind, multicenter study. - MAR-study. Metformin in assisted reporduction.

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 percent 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-DK

Lead Sponsor: Sigrun Kjøtrød

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

More than one year of infertility in PCOS-women planned for IVF og ICSI - First or second cycle of IVF og ICSI treatment. - Age below 38 years at inclusion. - BMI below 28 kg/m2 at inclusion. - Patient willing to be randomised to 4 month treatment with metformin or placebo. - If previously on methformin, a 1 month wash-out period is required. - PCOS diagnosis based on the revised ESHRE/ASMR-2003 (Rotterdam)-criteriae; fullfilling at least two of the following three criteriae: - Oligoamenorrhea - Hyperandrogenism - 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 above 10 IE/L - Known liver disease, or s-ALAT above 80 IU/L - Known renal disease, os s-kreatinin obove 130 mmol/L - Known alcoholism or drug abuse - known diabetes mellitus, or fasting serum-glucosis above 6.7 nmol/L - Peroral steroid hormone treatment - Treatment with cimetidin, anticoagulantia, erythromycin or other macrolides - Hyperprolactinemia (se-PRL above 700 IE/L) - Abnormal thyroid function tests - Congenital adrenal hyperplasia - Androgen secreting tumors - Cushing disease - Unfit to participate of any other reason.