Metformin treatment before IVF/ICSI in non obese women with polycystic ovarian syndrome . A European, prospective, randomised, double-blind, multicenter study. (MET-AR study ) - MET-AR study. Metformin in assisted reproduction.

Conditions: Polycystic ovary syndrome (PCOS) is a disorder characterized by polycystic ovaries, oligo-amenorrea and hyperandogenism. 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 criteriae used, and the population studied. A prevalence of five to seven percent has been reprted in Caucasian women.

Registration Number: EUCTR2004-001124-20-SE

Lead Sponsor: Sigrun Kjøtrød

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

--PCOS diagnosis based on the ESHRE/ASRM (Rotterdam may 03) criteria;-fulfilling at least two of the following three criteria - Oligo-amenorrea, hyperandrogenism and/or
PCO-ovaries by ultrasound.
-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 for 4 months treatment with metformin or placebo
-If previously on metformin, a one month wash-out period is required.
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

Exclusion Criteria

-More than one previous IVF-cycle
-Patients not suitable for starting dose 112.5 IE of Gonal F
-Basal-FSH above 10 IE
-Known liver disease or s-ALAT above 80 IU/L
-Known renal disease or s-Creatinine above above 110 mmol/l
-Known alcoholism or drug abuse
-Known diabetes mellitus, or fasting plasma-glucose above 7.0 mmol/L (= fasting whole blood glucose above 6.1 mmol/L)
-Peroral steroid hormone treatment
-Treatment with cimetidin, anticoaguantia, erythromycin or other macrolides
-Hyperprolactinemia or s-PRL above 700 IE/L
-Abnormal thyroid function tests
-Congenital adrenal hyperplasia
-Androgen secreting tumours
-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 non obese (BMI below 28 kg/m2) women with polycystic ovarian syndrome increase clinical pregnancy rate in IVF/ICSI?<br>Clinical pregnancy rate is defined as a verified intrauterine gestational sack by ultrasound week seven of pregnancy.;Secondary Objective: -Number of oocytes collected and embryo quality<br>-Dose of gonadotrophin, both daily and total used in IVF/ICSI cycle (ie costs of treatment) Also number of days of gonadotrophin treatment.<br>-s-Estradiol on day of hCG-injection, and occurrence of ovarian hyperstimulation syndome (OHSS)<br>-Spontaneous pregnancy rates during pretreatment period (ie before IVF/ICSI)<br>-Spontaneous abortion rates and finally live birth rates.<br><br>;Primary end point(s): Clinical pregnancy rate following IVF or ICSI treatment in non obese PCOS women.<br>Clinical pregnancy rate defined by an intrauterine gestational sack week 7 in pregnancy

Secondary Outcome Measures