Status:
TERMINATED
Metformin in Assisted Reproduction-MET-AR-study
Lead Sponsor:
Norwegian University of Science and Technology
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-38 years
Phase:
PHASE4
Brief 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...
Detailed Description
PCOS is an hormonal disease including hyperandrogenism, oligo-or anovulation and/or polycystic ovaries by ultrasound. PCOS women often suffer insulin resistance or even diabetes risk as well as a full...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00159575
Start Date
March 1 2005
End Date
April 1 2010
Last Update
January 5 2012
Active Locations (2)
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1
Sigrun Kjøtrød
Trondheim, Norway, 7006
2
Fertility UNit- -St Olavs Hospital
Trondheim, Norway, 7046