EUCTR2008-001174-33-AT进行中（未招募）不适用
A multinational, multicenter, exploratory pharmacogenomics trial to test the importance of identified genetic markers, and potentially identify new markers of various ovarian responses to GONAL-f® treatment in women undergoing assisted reproduction technology (ART). - Pharmacogenomics trial of GONAL-f® in ART
Merck Serono International, A branch of Laboratoires Serono S.A.0 个研究点目标入组 1,500 人开始时间: 2008年11月25日最近更新:
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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
- 1,500
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
- •Be between 30 and 39 years of age inclusive at the time of Informed Consent signature,
- •Have completed treatment with GONAL f® for an IVF or ICSI cycle within 6 months prior to informed consent signature (index cycle),
- •Have received a standard long GnRH agonist protocol (during the index cycle),
- •Both ovaries present,
- •Body mass index (BMI) =20 and <30 kg/m2,
- •Provided informed consent to enter the trial with the awareness that the genetic results of the trial will be kept anonymous, and that their medical specialist will not know their genetic results and thus, these will not influence their own future management.
- •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
- •Organic ovarian cysts >3cm during the index cycle including endometriomata,
- •Concomitant therapy to enhance GONAL-f® (steroids, growth hormone and LH except when LH has been used after Day 5, i.e. Day 6 or later, in subjects classified as suboptimal),
- •Major systemic disease (such as diabetes mellitus type 1 and 2),
- •Metformin therapy for infertility treatment within 2 months prior to or during GONAL-f® treatment (i.e., during the index cycle).
研究者
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