EUCTR2014-001835-35-ES进行中（未招募）1 期
Transdermal testosterone gel for poor ovarian responders. A multicenter double-blind placebo controlled randomized trial. - Testosterone TRANSdermal gel for Poor Ovarian Responders Trial (T-TRANSPORT)
niversitair Ziekenhuis Brussel0 个研究点目标入组 400 人开始时间: 2015年6月1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
- 400
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
- •Patients participating in the TTRANSPORT study will be women who are considered poor ovarian responders according to the ?Bologna criteria? (Ferrarretti et al., 2011). Patients between 18-43 years old will be eligible.
- •Patients should fulfill 2 out of 3 of the following criteira:
- •1. Age >or =40 years
- •2. At least 1 previous stimulated IVF/ICSI cycle with ?3 oocytes retrieved
- •3. Low ovarian reserve markers (antral follicle count <7 or antimullerian hormone levels<1.1ng/ml)
- •Women < 40 years old with normal AFC or AMH who underwent at least 2 previous stimulated IVF/ICSI cycles with ? 3 oocytes retrieved after maximum stimulation for IVF/ICSI, will also be considered eligible
- •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 400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Perimenopausal women with amenorrhea not having a regular cycle
- •2.Uterine abnormalities
- •3.Recent history of any current untreated endocrine abnormality
- •4.Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)
- •5.Contraindications for the use of gonadotropins
- •6.Recent history of severe disease requiring regular treatment
- •7.Use of androgens during the last 3 months
- •8.Patients with shBG values <20nmol/L or >160nmol/L
- •9.Azoospermia ( sperm derived through TESE)
研究者
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