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临床试验/NCT04876300
NCT04876300已完成不适用

Predicting the Cumulative Live Birth Rate Further Ovarian Stimulation by Highly Purified Human Menotropin HP-hMG. A Multicentre, Retrospective Study

Ferring Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 11,488 人开始时间: 2021年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11,488
试验地点
1
主要终点
Cumulative live birth rate (cLBR)

研究概览

简要总结

French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient undergoing a COS with HP-hMG for IVF/ICSI cycle from a French data registry between 2009 to 2016

排除标准

  • Ovulation inductions
  • Intra-uterine inseminations
  • Fertility preservations
  • Oocyte donations

结局指标

主要结局

Cumulative live birth rate (cLBR)

时间窗: At delivery

Defined as the occurence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.

次要结局

  • Initial dose of Menotropin treatment per IVF cycle (IU)(At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016)
  • Dose adjustment of Menotropin in IU(At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016)
  • Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (with in particular long and short agonist, and antagonist)(At the day of the first GnRH administration during the ovarian stimulation treatment (up to 20 days) in 2009 to 2016)
  • Total dose of Menotropin treatment per IVF cycle (IU)(At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016)
  • Total days of Menotropin treatment (per IVF cycle)(Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016)
  • Total days of LH surge suppression protocol(From Day 1 up to the last day of GnRH analogues administration during 2009 to 2016)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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