EUCTR2014-001835-35-BE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)
Fundación Santiago Dexeus Font (Dexeus)0 个研究点目标入组 400 人开始时间: 2015年3月2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” (Ferraretti et al., 2011).
- •Subjects must fulfil the following criteria to be included in the study:
- •1. All subjects must sign the Informed consent documents prior to screening evaluations.
- •2.Age: between 18-43 years old.
- •3.One of the features below:
- •Infertile female <40 years old with
- •i.= 3 oocytes in a previous cycle and AFC <7 OR
- •ii.ovarian surgery/chemotherapy and AFC<7 OR
- •iii.= 3 oocytes in at least 2 previous cycles with =300IU gonadotropins
- •Infertile female =40 years old with
- •i. = 3 oocytes in a previous cycle OR
- •ii. AFC <7.
- •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.Basal FSH >20 IU/l
- •3.Uterine malformations
- •4.Recent history of any current untreated endocrine abnormality
- •5.Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)
- •6.Contraindications for the use of gonadotropins
- •7.Recent history of severe disease requiring regular treatment
- •8.Use of androgens during the last 3 months
- •9.Patients with SHBG values <20nmol/L or >160nmol/L
- •10.Azoospermia (sperm derived through FNA or TESE)
研究者
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