Metformin in Assisted Reproduction-MET-AR-study

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index [BMI] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Fulfilling Rotterdam criteria for PCOS

• Infertility more than 1 year

• First or second cycle of IVF/ICSI treatment

• Age below 38 years at inclusion

• BMI below 28 kg/m3 at inclusion

• Willing to be randomised to 4 months metformin or placebo

• Signed written informed consent

Exclusion Criteria:

• Not suitable for starting dose 112.5 IE

• Basal FSH above 10 IU/L

• Known renal disease or s-creatinine above 110 umol/L

• Known liver disease or s-ALAT above 80 IU/L

• Known alcoholism or drug abuse

• Known diabetes mellitus or fasting plasma glucose above 7 mmol/L

• Corticosteroid treatment (oral)

• Treatment with cimetidine, anticoagulants, erythromycin or other macrolides

• Hyperprolactinemia (PRL above 700 mIU/L)

• Abnormal thyroid function tests

• Known congenital adrenal hyperplasia

• Androgen secreting tumours

• Cushing syndrome

• Metformin treatment within the last one month prior to screening

• Unfit to participate for any other reason