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.

Sigrun Kjøtrød0 个研究点目标入组 300 人开始时间: 2005年4月6日最近更新: 2012年5月1日

适应症

试验速览

暂无简介。

•--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

•-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

发起方

Sigrun Kjøtrød