EUCTR2004-001124-20-FI进行中（未招募）1 期
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.
Sigrun Kjøtrød0 个研究点目标入组 300 人开始时间: 2005年4月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 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
- •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 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
研究者
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终止
4 期
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