CTRI/2009/091/000888已完成3 期
Prospective, multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-020 in patients undergoing treatment for infertility.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 11
- 主要终点
- To assess the efficacy of R-TPR-020 in Hyper stimulation of ovaries.
研究概览
简要总结
This is a prospective, multicentric, open label, single arm clinical trial to evaluate the safety and efficacy of R-TPR-020 in infertile females undergoing controlled ovarian hyperstimalation or patients undergoing treatment for polycystic ovarian syndrome. Total 45 subjects will be enrolled across the centers in India. The primary outcome measure will be the number of oocyte retrived post 36 hours of beeta hCG administration. Study duration of study will be of 7 month (6 month recruitment, 2 weeks screening & 2 weeks treatment)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female subjects age 18 years to 40 years (both inclusive) at the time of screening.
- •2.Infertile females of couples undergoing for controlled ovarian hyperstimulation (COH) or patients undergoing treatment for Polycystic ovarian syndrome (PCOS).
- •3.Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening.
排除标准
- •1.History of clinically significant endocrine related abnormality 2.History / presence of undiagnosed vaginal bleeding 3.History of primary ovarian failure 4.Any ovarian and/or abdominal abnormality interfering with ultrasound examination; 5.History of clinically significant diseases, e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease 6.Use of hormonal preparations within one month prior to the start of FSH with the exception of thyroid medication.
结局指标
主要结局
To assess the efficacy of R-TPR-020 in Hyper stimulation of ovaries.
时间窗: Mean number of oocytes retrieved 36 hours post rhCG administration
次要结局
- 1.Assessment of oestradiol levels on the day of rhCG administration(2.Evaluation of safety)
研究者
研究点 (11)
Loading locations...
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