EUCTR2005-000500-13-GB进行中（未招募）1 期
Metformin treatment before IVF in women with ultrasound evidence of polycystic ovaries; a prospective, randomised, double blind, placebo controlled study
niversity of Oxford- Research Services0 个研究点目标入组 140 人开始时间: 2005年9月1日最近更新:
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
- 140
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
入选标准
- •Women attending the Oxford fertility unit with ovulatory PCO due to undergo IVF/ICSI treatment
- •First or second cycle of IVF/ICSI
- •If previously on metformin, a minimum one month washout period is required.
- •Polycystic ovaries diagnosed by ultrasound presence of 12 or more follicles in at least one ovary measuring 2-9 mm in diameter and/or increased ovarian volume (>10 ml)
- •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
- •Clinical manifestations of PCOS. i.e. any of the following –
- •1. Oligo- or amenorrhoea with cycles = 42 days apart
- •2. Anovulation with mid-luteal progesterone < 16 nmol/L.
- •3. Biochemical hyperandrogenism with serum testosterone = 3.5 mmol/L and / or free androgen index > 5.
- •4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly.
- •Two or more previous IVF cycles
- •Basal FSH > 12 iu/L
- •Liver disease or ALT > 80 iu/l
- •Renal disease, or creatinine > 130 _mol/l
- •Alcoholism or drug abuse
- •Diabetes mellitus (evaluated by fasting glucose > 6.7mmol/l)
- •Per oral steroid treatment in last month
- •Cimetidine, anticoagulation, erythromycin, or other macrolides in last month
- •Hyperprolactinemia (Prolactin > 700 mU/L)
- •Abnormal thyroid function tests (TSH outside of laboratory normal range)
- •Congenital adrenal hyperplasia
研究者
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