NCT04503707已完成不适用
French Prospective Multicentre Non-Interventional Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- Daily dose of REKOVELLE administered (for naïve and non-naïve subjects)
研究概览
简要总结
The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 years or older at enrolment
- •Who are treated for IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor
- •Who are prescribed REKOVELLE for the first time and using the dosing algorithm to define the dose regimen: a previous cycle with REKOVELLE should not be allowed
- •Who have been informed verbally and in writing about this study content and who do not object to their data being electronically processed.
排除标准
- •Participating in an interventional clinical trial in which any treatment or follow-up is mandated
- •Women with a contraindication for prescription of REKOVELLE treatment
- •Oocyte donors
- •Women undergoing ovarian stimulation for fertility preservation
- •Women undergoing their third or fourth attempt of IVF or ICSI for the current parental project.
- •Subject non-affiliated to French Social Security
- •Women placed under judicial protection, guardianship, or supervision
研究组 & 干预措施
Follitropin Delta
Treatment according to routine clinical practice.
干预措施: Follitropin Delta (Drug)
结局指标
主要结局
Daily dose of REKOVELLE administered (for naïve and non-naïve subjects)
时间窗: At the end of the stimulation protocol (up to 30 days)
Duration of treatment with REKOVELLE (for naïve and non-naïve subjects)
时间窗: From first until last day of REKOVELLE treatment (up to 30 days)
Treatment used for Luteal phase support (for naïve and non-naïve subjects)
时间窗: From start of REKOVELLE treatment until 10-11 weeks after embryo transfer
Decided as a choice between Progesterone, Oestrogen and hCG
Use of the dosing App (for naïve and non-naïve subjects)
时间窗: At visit when the daily dose of REKOVELLE is decided (up to 2 hours)
Type of Gonadotropin-Releasing Hormone (GnRH) used (for naïve and non-naïve subjects)
时间窗: At visit (up to 2 hours) during the REKOVELLE treatment period
Duration of treatment with GnRH (for naïve and non-naïve subjects)
时间窗: At the end of the ovarian controlled stimulation (up to 2 weeks)
Treatment used for the triggering of follicle maturation (for naïve and non-naïve subjects)
时间窗: At the last visit during the REKOVELLE treatment period (from 5 to 30 days)
次要结局
- Number of oocytes retrieved (for naïve and non-naïve subjects)(At visit (up to 2 hours) at 36 hours after completed REKOVELLE treatment)
- Quality of fresh or frozen embryos or blastocysts transferred (excellent, good, fair, other) (for naïve and non-naïve subjects)(At Day 3, 5 or 6 after oocyte retrieval)
- Incidence of ectopic pregnancy (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Proportion of subjects with cycle cancellation (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Type of gonadotropin used (previous cycle information for non-naïve subjects)(At baseline)
- Proportion of subjects with preventive interventions for early OHSS (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Frequency of adverse drug reactions (ADR) (for naïve and non-naïve subjects)(From start of REKOVELLE treatment until 10-11 weeks after embryo transfer)
- Rate of Ongoing Pregnancy (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Number of oocytes/embryos/blastocysts frozen (for naïve and non-naïve subjects)(At Day 3 after oocyte retrieval)
- Incidence of biochemical pregnancy (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Implantation rate (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Positive human chorionic gonadotropin (hCG) test (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Clinical pregnancy rate (for naïve and non-naïve subjects)(Up to 5-6 weeks after transfer)
- Incidence of spontaneous abortion (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Incidence of elective abortion (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Incidence of vanishing twins (for naïve and non-naïve subjects)(Up to 10-11 weeks after transfer)
- Dose of gonadotropin used (previous cycle information for non-naïve subjects)(At baseline)
- Duration of treatment with gonadotropin (previous cycle information for non-naïve subjects)(At baseline)
- Type of GnRH used (previous cycle information for non-naïve subjects)(At baseline)
- Duration of treatment with GnRH (previous cycle information for non-naïve subjects)(At baseline)
- Treatment used for the triggering of follicle maturation (previous cycle information for non-naïve subjects)(At baseline)
- Treatment used for Luteal phase support (previous cycle information for non-naïve subjects)(At baseline)
- Number of oocytes retrieved (previous cycle information for non-naïve subjects)(At baseline)
- Number of embryos/blastocysts transferred (previous cycle information for non-naïve subjects)(At baseline)
- Incidence of pregnancy loss in women with embryo/blastocyst transfer (previous cycle information for non-naïve subjects)(At baseline)
- Proportion of subjects with OHSS including moderate/severe grade (previous cycle information for non-naïve subjects)(At baseline)
- Proportion of subjects with preventive interventions for early OHSS (previous cycle information for non-naïve subjects)(At baseline)
- Monitoring of the REKOVELLE treatment (number and intents of each visit) (for naïve and non-naïve subjects)(From Day 1 up to the last day of REKOVELLE stimulation)
研究者
研究点 (14)
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