NCT04227171已完成不适用
A Multicenter, Prospective Cohort Observational Study to Develop Dosing Chart Based on Patient Specific Characteristics and Ovarian Response When Follitrope™ PFS is Administered Subcutaneously to Infertility Women Patients
LG Chem1 个研究点 分布在 1 个国家目标入组 534 人开始时间: 2018年8月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved
研究概览
简要总结
To confirm the predictors based on patient specific characteristics and ovarian response and develop dosing chart when Follitrope™ PFS is administered to infertility women patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged of 19 to 39 years
- •Mean menstrual cycle in 25 to 35 days
- •Patients to whom Follitrope PFS will be administered in those scheduled to undergo the IVF-ET according to the GnRH agonist or antagonist protocol
- •In the past continuous IVF cycle failure less than 2 times
排除标准
- •Patients having a history of ovarian, breast, uterus, hyperthalamus, or pituitary tumor
- •Abnormal uterine bleeding of undetermined origin
- •Prior hypersensitivity to a component of recombinant FSH
- •Ovarian cyst or enlargement of undetermined origin
- •Clinically significant endocrine abnormalities
- •Patients having polycystic ovary syndrome (PCOS) history
- •Poor Ovarian responder (Bologna criteria)
- •Patients who received Clomiphene citrate, Letrozole (Pemara), or Gonadotropin within 30 days prior to enrollment in this study
结局指标
主要结局
No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved
时间窗: after OPU, normally 2 weeks
Number of oocyte identified by ovum pick up (OPU) after overovulation
次要结局
- clinical pregnancy rate(24 days after OPU)
- Fertilization rate(1~2 days after OPU)
- Total dose (IU) of Follitrope™ PFS administered(2 weeks)
- Number of embryo transferred(3~5 days after OPU)
- pregnancy rate(up to 10 weeks after OPU)
- Total duration (days) of Follitrope™ PFS administered(2 weeks)
- Oocyte maturity quality(after OPU, normally 2 weeks)
- Biochemical pregnancy rate(10 days after OPU)
- E2 concentration on hCG day(normally 10 days)
- P4 concentration on hCG day(normally 10 days)
- Implantation rate(24 days after OPU)
研究者
研究点 (1)
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