Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
18 Years
38 Years
Female
Polycystic Ovary Syndrome
Trial Information
Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
Vaginal ultrasound in pregnancy week 7
Safety Issue:
No
Principal Investigator
Sven Carlsen, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
St Olavs Hospital- Endocrinological section
Authority:
Norway: Norwegian Medicines Agency
Study ID:
MET-AR study -PCOS 5
NCT ID:
NCT00159575
Start Date:
March 2005
Completion Date:
April 2010
Related Keywords:
- Polycystic Ovary Syndrome
- Polycystic ovarian syndrome
- Clinical pregnancy rate
- Oligo- or anovulation
- Polycystic Ovary Syndrome
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