Metformin in Assisted Reproduction-MET-AR-study
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin / Placebo treatment for 4 months |
Phase | Phase 4 |
Sponsor | Norwegian University of Science and Technology |
Responsible Party | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier | NCT00159575 |
First Received | September 9, 2005 |
Last Updated | January 2, 2012 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | September 9, 2005 |
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Last Updated Date | January 2, 2012 |
Start Date | March 2005 |
Estimated Primary Completion Date | April 2010 |
Current Primary Outcome Measures | To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women [Time Frame: Vaginal ultrasound in pregnancy week 7] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Metformin in Assisted Reproduction-MET-AR-study |
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Official Title | Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome |
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-weight (body mass index [BMI] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women. |
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 blown metabolic disease. These women often suffer infertility due to their lack of regular ovulations. Metformin is a well known anti-diabetic drug, and in some PCOS women metformin might decrease the hyperandrogenism, improve insulin resistance and give more regular ovulations. Thereby increase chance of pregnancy. Our hypothesis is that metformin will increase clinical pregnancy rates both spontaneously and following IVF/ICSI. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin / Placebo treatment for 4 months M: Metformin 2000mg daily- 12-14 weeks of pretreatment + metformin 2000mg daily through conventional IVF ending on the day of pregnancy test; IE. 14 days after embryo transfer. P: Or identical placebo treatment for the same period |
Study Arm (s) | Experimental: M: Metformin P: Placebo |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 150 |
Estimated Completion Date | April 2010 |
Estimated Primary Completion Date | August 2009 |
Eligibility 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 |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Norway |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00159575 |
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Other Study ID Numbers | MET-AR study -PCOS 5 |
Has Data Monitoring Committee | No |
Information Provided By | Norwegian University of Science and Technology |
Study Sponsor | Norwegian University of Science and Technology |
Collaborators | Not Provided |
Investigators | Study Chair: Sven Carlsen, MD,PhD St Olavs Hospital- Endocrinological section |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
Fertility UNit- -St Olavs Hospital | Trondheim, Norway, 7046 |
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Sigrun Kjøtrød | Trondheim, Norway, 7006 |