EUCTR2004-001124-20-DK进行中（未招募）不适用
Metformin treatment before IVF/ICSI in normal weight women with polycystic ovarian syndrome. A European, prospective, randomised, double blind, multicenter study. - MAR-study. Metformin in assisted reporduction.
Sigrun Kjøtrød0 个研究点目标入组 300 人开始时间: 2005年2月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •More than one year of infertility in PCOS-women planned for IVF og ICSI - First or second cycle of IVF og 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 methformin, a 1 month wash-out period is required. - PCOS diagnosis based on the revised ESHRE/ASMR-2003 (Rotterdam)-criteriae; fullfilling 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
排除标准
- •More than one previous IVF cycle - Patients not suitable for starting dose 112.5 IE Gonal-F. - Basal s-FSH above 10 IE/L - Known liver disease, or s-ALAT above 80 IU/L - Known renal disease, os s-kreatinin obove 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 (se-PRL above 700 IE/L) - Abnormal thyroid function tests - Congenital adrenal hyperplasia - Androgen secreting tumors - Cushing disease - Unfit to participate of any other reason.
研究者
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