NCT06561958进行中（未招募）不适用
Prospective, Multi-country, Non-Interventional Study to Investigate REKOVELLE for Ovarian Stimulation: the Effectiveness, Safety, and Patterns Of Use for Asian Women in Real World Practice
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 35
- 主要终点
- Cumulative live birth rate
研究概览
简要总结
Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 20 years or older at enrollment
- •Serum AMH level >0.5 ng / mL (with the latest result tested within 12 months)
- •Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable)
- •Willing and able to provide written informed consent
排除标准
- •Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment
- •Participating in an interventional clinical trial in which any medication treatment is mandated
- •Women with a contraindication for prescription of REKOVELLE treatment
- •Oocyte donors
- •Undergoing ovarian stimulation for fertility preservation
研究组 & 干预措施
REKOVELLE
Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation.
干预措施: REKOVELLE (Drug)
结局指标
主要结局
Cumulative live birth rate
时间窗: Up to 12 months
Cumulative live birth rate defined as delivery of at least 1 live fetus after 20 completed weeks of gestation, combined fresh and frozen embryo transfers within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.
次要结局
- Number of oocytes retrieved(Up to 22 days)
- Frequency and severity of adverse drug reactions (ADRs) and serious adverse events (SAEs)(During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer)
- Number of blastocysts transferred(Up to 28 days)
- Daily Dosage(Up to 22 days)
- Luteal phase support protocol(Up to 22 days)
- The Luteinising hormone (LH) surge suppression protocol(Up to 22 days)
- Implantation rate(Up to 28 days)
- Multiple pregnancy rate(4 to 5 weeks after transfer)
- Spontaneous abortion rate(Up to 10-11 weeks after transfer)
- Progesterone Hormone levels(Up to 20 days)
- Transfer cancellation rate and the reason for transfer cancellation(Up to 28 days)
- Preventive interventions for ovarian hyperstimulation syndrome (OHSS)(During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer.)
- Number of subjects with mild / moderate / severe ovarian hyperstimulation syndrome (OHSS)(During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer)
- Trigger Protocol(Up to 22 days)
- Number of Metaphase II (MII) oocytes(Up to 22 days)
- Number of embryos(Day 3 after oocyte retrieval)
- Time to pregnancy(4 to 5 weeks after transfer)
- Live birth rate(More than 20 weeks after transfer)
- Stimulation Duration(Up to 22 days)
- Total Dosage(Up to 22 days)
- Number of Blastocysts(Day 5 after oocyte retrieval)
- Number of embryos transferred(Up to 28 days)
- Positive human chorionic gonadotropin (hCG) rate(11 to 15 days after transfer)
- Clinical Pregnancy rate(4 to 5 weeks after transfer)
- Vital Pregnancy(4 to 5 weeks after transfer)
- Estradiol Hormone levels(Up to 20 days)
- Ongoing pregnancy rate(9 to 11 weeks after transfer)
- Ectopic pregnancy rate(Up to 10-11 weeks after transfer)
- Cycle cancellation rate and the reason for cycle cancellation(Up to 28 days)
研究者
研究点 (35)
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