Nordics and Switzerland Prospective Multicentre Non-Interventional Observational Study to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice (NORSOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered)
研究概览
简要总结
Study designed to observe the usage patterns, efficacy and safety of REKOVELLE® in women naive to IVF and ICSI, undergoing their first Controlled Ovarian Stimulation (COS) treatment cycle with REKOVELLE® in routine clinical practice.
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 have never been treated with (naïve) in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment using fresh or frozen ejaculated sperm from male partner or sperm donor
- •Who are prescribed REKOVELLE® for the first time, using the dosing algorithm-based on AMH test result and body weight to define the 1st cycle dose regimen with REKOVELLE® according to the approved label
- •Who have been informed verbally and in writing about this trial content, signed the inform consent and who do not object to their data being electronically processed
排除标准
- •Currently participating in an interventional clinical trial in which any treatment or follow-up is mandated
- •Women with a contraindication for prescription of REKOVELLE® treatment
- •Hypersensitivity to the active substance or to any of the excipients
- •Tumours of the hypothalamus or pituitary gland
- •Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
- •Gynaecological haemorrhages of unknown aetiology
- •Ovarian, uterine, or mammary carcinoma
- •Primary ovarian failure
- •Malformations of sexual organs incompatible with pregnancy
- •Fibroid tumours of the uterus incompatible with pregnancy
- •Pregnancy and breast feeding
- •Women who undergo ovarian stimulation for fertility preservation
- •Women placed under judicial protection, guardianship, or supervision
- •Women who are considered as vulnerable population
研究组 & 干预措施
REKOVELLE®
干预措施: REKOVELLE® (Drug)
结局指标
主要结局
Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered)
时间窗: Up to day 1 of REKOVELLE® stimulation
Calculated with body weight and AMH serum level to define the daily dose of REKOVELLE®
Daily dose of REKOVELLE®
时间窗: From day 1 up to day 20 of REKOVELLE® stimulation
REKOVELLE® Dose changes
时间窗: From day 1 up to day 20 of REKOVELLE® stimulation
Dose changes is the discretion of the investigator
Use of GnRH protocol for Lutenizing Hormone surge suppression
时间窗: Up to day 10
Defined as a choice between GnRH agonist and GnRH antagonist
Number of days of treatment with REKOVELLE®
时间窗: From day 1 up to day 20 of REKOVELLE® stimulation
Use of the Algorithm dosing Application
时间窗: Up to day 1 of REKOVELLE® stimulation
Use of the Ferring developed dosing app for the daily dose calculation by answering yes/no
Type of drug used for triggering of follicle maturation
时间窗: Between Day 8 and Day 14
Defined as a choice between hCG or GnRH
Luteal phase support
时间窗: 24-72 hours after oocyte-retrieval
Type and the length of luteal phase support is the discretion of the investigator. Decided as a choice between Progesterone, Oestrogen and hCG
次要结局
- Number of oocytes retrieved(Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) at 34-36 hours)
- Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) in the fresh cycle(10-11 weeks after embryo transfer)
- Positive signs of pregnancy (clinical pregnancy)(Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 5-6 weeks after embryo transfer)
- Positive signs of pregnancy (Positive Human chorionic gonadotropin (hCG) test or urine pregnancy test)(Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 10-11 weeks after embryo transfer)
- Pregnancy loss in women with embryo/blastocyst transfer (biochemical pregnancy, spontaneous/elective abortion, ectopic pregnancy, vanishing twin)(Up to 10-11 weeks after embryo transfer)
- Adverse drug reactions (ADRs)(During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.)
- Ovarian hyperstimulation syndrome (OHSS) (including mild/moderate/severe)(During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.)
- Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) following the fresh cycle, including also the first frozen embryo transfer(10-11 weeks after embryo transfer)
- Number of oocytes/embryos/blastocysts frozen(Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval)
- Quality of fresh embryos or blastocysts transferred (excellent, good, fair, other)(Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval)
- Cycle cancellation before or after oocyte pick-up and reason for cycle cancellation(At consultation visit where cycle cancellation decided up to 10-11 weeks after embryo transfer)
- Assessment of overall subject experience and convenience with REKOVELLE® by the Subject Questionnaire (assessed by the subject)(34-36 hours after final injection of 1st cycle with REKOVELLE® (average 9 days))
- Number of embryos/blastocysts transferred(Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval)
- Preventive interventions for early OHSS(During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.)