Clinical trial NCT04503707: Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Controlled Ovarian Stimulation
Keywords: Follicle Stimulating Hormone (FSH)
Assisted Reproductive Technologies (ART)
Follitropin Delta
REKOVELLE
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are prescribed REKOVELLE within the approved indication for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment will be invited to participate in the study. Subjects will be enrolled only after the treatment decision has been made and no aspect of this study will interfere with or influence the routine medical procedures and/or medications received.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Daily dose of REKOVELLE administered (for naïve and non-naïve subjects)
timeFrame: At the end of the stimulation protocol (up to 30 days)
measure: Duration of treatment with REKOVELLE (for naïve and non-naïve subjects)
timeFrame: From first until last day of REKOVELLE treatment (up to 30 days)
measure: Use of the dosing App (for naïve and non-naïve subjects)
timeFrame: At visit when the daily dose of REKOVELLE is decided (up to 2 hours)
measure: Type of Gonadotropin-Releasing Hormone (GnRH) used (for naïve and non-naïve subjects)
timeFrame: At visit (up to 2 hours) during the REKOVELLE treatment period
measure: Duration of treatment with GnRH (for naïve and non-naïve subjects)
timeFrame: At the end of the ovarian controlled stimulation (up to 2 weeks)
measure: Treatment used for the triggering of follicle maturation (for naïve and non-naïve subjects)
timeFrame: At the last visit during the REKOVELLE treatment period (from 5 to 30 days)
measure: Treatment used for Luteal phase support (for naïve and non-naïve subjects)
timeFrame: From start of REKOVELLE treatment until 10-11 weeks after embryo transfer
Secondary outcomes:
measure: Rate of Ongoing Pregnancy (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Number of oocytes retrieved (for naïve and non-naïve subjects)
timeFrame: At visit (up to 2 hours) at 36 hours after completed REKOVELLE treatment
measure: Number of oocytes/embryos/blastocysts frozen (for naïve and non-naïve subjects)
timeFrame: At Day 3 after oocyte retrieval
measure: Quality of fresh or frozen embryos or blastocysts transferred (excellent, good, fair, other) (for naïve and non-naïve subjects)
timeFrame: At Day 3, 5 or 6 after oocyte retrieval
measure: Implantation rate (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Positive human chorionic gonadotropin (hCG) test (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Clinical pregnancy rate (for naïve and non-naïve subjects)
timeFrame: Up to 5-6 weeks after transfer
measure: Incidence of biochemical pregnancy (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Incidence of spontaneous abortion (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Incidence of elective abortion (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Incidence of vanishing twins (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Incidence of ectopic pregnancy (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Proportion of subjects with cycle cancellation (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Type of gonadotropin used (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Dose of gonadotropin used (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Duration of treatment with gonadotropin (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Type of GnRH used (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Duration of treatment with GnRH (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Treatment used for the triggering of follicle maturation (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Treatment used for Luteal phase support (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Number of oocytes retrieved (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Number of embryos/blastocysts transferred (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Incidence of pregnancy loss in women with embryo/blastocyst transfer (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Proportion of subjects with OHSS including moderate/severe grade (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Proportion of subjects with preventive interventions for early OHSS (previous cycle information for non-naïve subjects)
timeFrame: At baseline
measure: Proportion of subjects with preventive interventions for early OHSS (for naïve and non-naïve subjects)
timeFrame: Up to 10-11 weeks after transfer
measure: Frequency of adverse drug reactions (ADR) (for naïve and non-naïve subjects)
timeFrame: From start of REKOVELLE treatment until 10-11 weeks after embryo transfer
measure: Monitoring of the REKOVELLE treatment (number and intents of each visit) (for naïve and non-naïve subjects)
timeFrame: From Day 1 up to the last day of REKOVELLE stimulation
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: BRON cedex
country: France
facility: Hôpital Femme Mère Enfant
city: Clamart
country: France
facility: Hopital Antoine Béclère
city: Creteil Cedex
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Lille Cedex
country: France
facility: Centre hospitalier de Lille-Hopital de Flandre
city: Marseille
country: France
facility: Institut de Médecine de la Reproduction (there may be other sites in this country)
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes Hôpital Hôtel Dieu
city: Paris
country: France
facility: Maternité Port Royal
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal de Poissy
city: Rennes
country: France
facility: Clinique Mutualiste La Sagesse
city: Rueil-Malmaison
country: France
facility: Pierre OGER
city: Strasbourg
country: France
facility: CMCO
city: Toulouse Cedex 9
country: France
facility: CHU Toulouse - Hôpital Paule de Viguier
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: