EUCTR2008-001174-33-ES进行中（未招募）1 期
A mulitnational, 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).Ensayo exploratorio farmacogenómico, multinacional y multicéntrico, para examinar la importancia de los marcadores genéticos identificados y, potencialmente, identificar nuevos marcadores de diversas respuestas ováricas al tratamiento con GONAL f® en mujeres sometidas a técnicas de reproducción asistida (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 0 人开始时间: 2010年2月17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
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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