A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal females between the ages of 18 and 39 years
- •Documented history of infertility
- •Body mass index (BMI) between 17.5 and 32.0 kg/m2
- •Regular menstrual cycles
排除标准
- •Known endometriosis stage III and IV
- •Known polycystic ovarian syndrome (PCOS)
- •History of recurrent miscarriage
- •History of more than three previous controlled ovarian stimulation cycles
研究组 & 干预措施
HP-hCG IM
highly purified human chorionic gonadotropin, intramuscularly (IM)
干预措施: highly purified human chorionic gonadotropin (Drug)
HP-hCG SC
highly purified human chorionic gonadotropin, subcutaneously (SC)
干预措施: highly purified human chorionic gonadotropin (Drug)
rhCG
recombinant human chorionic gonadotropin
干预措施: recombinant human chorionic gonadotropin (Drug)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: Approximately 36 hours after hCG administration
Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.
次要结局
- Frequency of Adverse Events (AEs)(AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented)
- Number of Metaphase II (MII) Oocytes(Prior to insemination (within 6 hours after oocyte retrieval))
- Intensity of AEs(AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.)
- Number of Fertilized (2 Pronuclei (2PN)) Oocytes(One day after oocyte retrieval)
- Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate(13-15 days after transfer)
- Clinical Pregnancy Rate(5-6 weeks after transfer)