CTRI/2010/091/001063已完成3 期
Prospective, multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-013 in patients undergoing treatment for infertility
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 10
- 主要终点
- To assess the efficacy of R-TPR-013.
研究概览
简要总结
This study is a prospective, open label, multicentric trial to evaluate the efficacy and safety of R-TPR-013 in females undergoing treatment for Infertility. The study will be conducted in 10 centers across India. Primary end point will be evaluation of oocyte after R-TPR-013 administration. The secondary end point will be evaluation of safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
入选标准
- •Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening.
- •Female subjects age 18 years to 37 years (both inclusive) at the time of screening.
- •Infertile females of couples undergoing for controlled ovarian hyperstimulation (COH).
排除标准
- •History of clinically significant endocrine related abnormality
- •Any ovarian and/or abdominal abnormality interfering with ultrasound examination
- •History of clinically significant diseases e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease or PCOS
- •Subjects positive for HIV, HBsAg, HCV.
- •Subject participation in another clinical trial 30 days prior to administration of IP.
- •Any other condition which investigator feels would pose a significant hazard to subject if IP is administered.
- •Subject with history of alcohol or drug abuse within 12 months prior to signing informed consent.
结局指标
主要结局
To assess the efficacy of R-TPR-013.
时间窗: Assessment of oocytes post R-TPR-013 administration
次要结局
- Evaluation of safety(Evaluation of safety will be based on incidence of treatment-emergent adverse)
研究者
研究点 (10)
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