Trial 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
- Registration Number
- NCT05499052
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 201
- 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
-
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
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Women placed under judicial protection, guardianship, or supervision
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Women who are considered as vulnerable population
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description REKOVELLE® REKOVELLE® -
- Primary Outcome Measures
Name Time Method Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered) 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® From day 1 up to day 20 of REKOVELLE® stimulation REKOVELLE® Dose changes 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 Up to day 10 Defined as a choice between GnRH agonist and GnRH antagonist
Number of days of treatment with REKOVELLE® From day 1 up to day 20 of REKOVELLE® stimulation Use of the Algorithm dosing Application 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 Between Day 8 and Day 14 Defined as a choice between hCG or GnRH
Luteal phase support 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
- Secondary Outcome Measures
Name Time Method 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 Clinical pregnancy defined as least one gestational sac.
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 Biochemical pregnancy is defined as positive beta hCG (βhCG) test but no gestational sac is observed on later transvaginal ultrasound, or menstruation is reported.
Spontaneous abortion is defined as positive βhCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there are no viable fetuses observed by ultrasound.
Elective abortion is defined as induced abortion done at the request of the woman for other than therapeutic reasons.
Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.
Vanishing twin is defined as spontaneous disappearance of an intrauterine gestational sac with or without heart beat in a pregnancy where one viable fetus remains as documented by ultrasound.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. Adverse drug reactions (ADRs) defined by the investigator
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. OHSS defined by the investigator (including mild/moderate/severe)
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 Date when the investigator decides to cancel cycle before oocyte pick up (due to poor ovarian response, excessive ovarian response, any illness which prevents oocyte collection procedure, subject not taking hCG injection at the correct time, subject choice, other) or after oocyte pick-up (due to no oocytes collected, no oocytes fertilized, abnormal fertilization, abnormal embryo development, no embryo development, OHSS, subject choice, other)
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. Preventive interventions decided by the investigator (Triggering of final follicular maturation with GnRH agonist and fresh embryo/blastocyst transfer or cryopreservation, Cancellation of fresh embryo/blastocyst transfer)
Trial Locations
- Locations (1)
Ferring Investigational Site
🇨🇭Basel, Switzerland