EUCTR2004-001124-20-GB进行中（未招募）不适用
Metformin treatment before IVF/ICSI in normal weight women with polycystic ovarian syndrome. A Europeah, prospective, randomised, double blind, multicenter study. - MET-AR study. Metformin in assisted reproduction.
Sigrun Kjotrod0 个研究点目标入组 300 人开始时间: 2005年6月29日最近更新:
相关药物
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
- •Infertile (> 1 year) PCOS-women planned for treatment with IVF/ICSI
- •First or second cycle of IVF/ICSI - treatment
- •Age < 38 years at inclusion
- •BMI < 28 kg/m² at inclusion
- •Patient willing to be randomised to 4 months treatment with metformin or placebo
- •Patient has given written informed consent
- •If previously on metformin, a one-month washout period is required before inclusion.
- •PCOS –diagnosis based on the Rotterdam revised criteria 2003 / ESHRE-ASRM criteria – fulfilling at least two out of the following three criteria:
- •1.Oligo-amenorrea.
- •2.Hyperandrogenism
- •3.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 more than 10 IU/L
- •Known liver disease, or s-ALAT > 80 IU/l
- •Known renal disease, or s-kreatinin > 130 mmol/l
- •Known alcoholism or drug abuse
- •Known diabetes mellitus or fasting plasma glucose =6.7 mmol/L
- •Per oral steroid hormone treatment
- •Treatment with cimetidin, anticoagulantia, erythromycin, or other macrolides.
- •Hyperprolactinemia (s-Prolactin > 700 mIE/L)
- •Abnormal thyroid function tests
- •Congenital adrenal hyperplasia
- •Androgen secreting tumors
- •Cushing’s syndrome
- •Unfit to participate of any other reason
研究者
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终止
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