EUCTR2018-004604-20-BE进行中（未招募）1 期
Myo-inositol versus clomiphene citrate as first line treatment for ovulation induction in PCOS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled:
- •-irregular cycle (shorter than 21 days or longer than 35 days);
- •-clinical (modified Ferriman-Gallwey score = 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and-Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx);
- •-PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and-Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (= 20 per ovary and/or an ovarion volume = 10 ml, measured with a probe >8 MHz) in both ovaries.
- •Age: 18 until 40 years old (extremes included).
- •A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons:
- •-mild male factor (as defined by each local center)
- •-endometriosis AFS score 1 or 2
- •Use of own or donor sperm.
- •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 320
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Tubal factors
- •-Uterine factors
- •-Endometriosis AFS score 3 or 4
- •-Moderate to severe male factor (as defined by each local center)
- •-BMI > 35
研究者
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