Metformin treatment before IVF/ICSI in normal weight women with polycystic ovarian syndrome. A European, prospective , randomised, double blind, multicenter study. - MET-AR study. Metformin in assisted reproduction.
- 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-FI
- Lead Sponsor
- Sigrun Kjøtrød
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 300
-More than one year of infertility in PCOS-women planned for IVF or ICSI
-First or second cycle of IVF or 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 metformin, a 1 month wash-out period is required
-PCOS-diagnosis based on the revised ESHRE/ASRM-2003 (Rotterdam)-criteriae;
fulfilling 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
-More than one previous IVF-cycle
-Patients not suitable for starting dose 112.5 IE Gonal F
-Basal s-FSH above 10IE/L
-Known liver disease, or s-ALAT above 80 IU/l
-Known renal disease, os s-kreatinin above 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 (s-PRL above 700 IE/L)
-Abnormal thyroid function tests
-Congenital adrenal hyperplasia
-Androgen secrteting tumors
-Cushing disease
-Unfit to participate of any other reason
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does metformin treatment before IVF/ICSI in women with polycystic ovarian syndrome and normal body weight (BMI below 28 kg/m2) increase clinical pregnancy rate in IVF/ICSI?<br>Clinical pregnancy rate defined as a verified intrauterine gestational sack week 7 in pregnancy.;Secondary Objective: -Number of oocytes collected<br>-Embryo quality<br>-Number of days with gonadotrophin treatment in IVF cycle (ie. costs)<br>-Dose of gonodotrophin, total pr cycle and daily<br>-S-estradiol on day of hCG-injection<br>-Occurrence of Ovarian Hyperstimulation Syndrome (OHHS)<br>-Spontaneous pregnancy rates during pretreatment period.<br>-Spontaneous abortion rates <br>-Live birth rates;Primary end point(s): Clinical pregnancy rate following IVF or ICSI treatment in normal weight PCOS-women.<br>Clinical pregnancy rate defined by an intrauterine gestaional sack week 7 in pregnancy.<br>
- Secondary Outcome Measures
Name Time Method