An Exploratory Study to Explore the Correlation Between the Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response Using New Gonal-f® Pen in Assisted Reproductive Technology (ART) Treatment in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,064
- 试验地点
- 1
- 主要终点
- Number of subjects with polycystic ovary
研究概览
简要总结
This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of PCOS and examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for individualized controlled ovarian stimulation (iCOS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged 20 to 35 years (including both)
- •Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG)
- •Subject from whom a written informed consent has been obtained with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
排除标准
- •Subjects undergoing ART treatment with mild stimulation protocol
- •Concomitant use of Gonal-f® with clomiphene citrate
- •With an In vitro fertilisation (IVF)/ Intracytoplasmic sperm injection (ICSI) history of greater than or equal to (>=) 3 times
- •Known history of poor ovarian response in a previous COS cycle for IVF/ICSI, defined as less than 4 oocytes retrieved or history of previous cycle cancellation prior to oocyte retrieval due to poor response or poor ovarian reserve, such as Antral follicle count (AFC) less than (<) 5 to 7
- •Presence of confirmed or suspected endometriosis Grade III - IV
- •Presence of unilateral or bilateral hydrosalpinx
- •Using other Gn during stimulation period (such as urinary FSH/human menopausal Gn, except for recombinant luteinizing hormone (r-LH))
- •Known history of recurrent miscarriage
- •Any contradiction to Gn/GnRH analogues
- •Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
- •According to the judgment of the Investigator, any medical condition or any concomitant
- •surgery/ medications that would interfere with evaluation of study medications
- •Simultaneous participation in another clinical study
研究组 & 干预措施
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant
Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG) as per routine clinical practice. No visits or intervention(s) additional to the routine practice of the Investigators will be performed during this observational study.
干预措施: Gonal-f® (Drug)
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant
Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG) as per routine clinical practice. No visits or intervention(s) additional to the routine practice of the Investigators will be performed during this observational study.
干预措施: Long GnRH agonist (Drug)
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant
Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG) as per routine clinical practice. No visits or intervention(s) additional to the routine practice of the Investigators will be performed during this observational study.
干预措施: GnRH antagonist (Drug)
结局指标
主要结局
Number of subjects with polycystic ovary
时间窗: Baseline
Serum Testosterone levels
时间窗: Baseline
Number of subjects with history of menstrual disorders
时间窗: Baseline
Number of subjects with hirsutism
时间窗: Baseline
Number of oocytes retrieved
时间窗: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
次要结局
- Implantation Rate(4 to 6 Weeks after Embryo transfer (Up to 4 months))
- Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)(Baseline up to 1 month)
- Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)(Baseline up to 1 month)
- Biochemical pregnancy rate(4 to 6 Weeks after Embryo transfer (Up to 4 months))
- Number of Metaphase II (M II) oocyte retrieved(Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days))
- Clinical pregnancy rate(4 to 6 Weeks after Embryo transfer (Up to 4 months))
- Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)(Baseline up to 13 month)
- Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)(Baseline up to 13 month)