Clinical trial NCT05499052: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Controlled Ovarian Stimulation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are prescribed REKOVELLE® undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered)
timeFrame: Up to day 1 of REKOVELLE® stimulation
measure: Daily dose of REKOVELLE®
timeFrame: From day 1 up to day 20 of REKOVELLE® stimulation
measure: Number of days of treatment with REKOVELLE®
timeFrame: From day 1 up to day 20 of REKOVELLE® stimulation
measure: REKOVELLE® Dose changes
timeFrame: From day 1 up to day 20 of REKOVELLE® stimulation
measure: Use of the Algorithm dosing Application
timeFrame: Up to day 1 of REKOVELLE® stimulation
measure: Use of GnRH protocol for Lutenizing Hormone surge suppression
timeFrame: Up to day 10
measure: Type of drug used for triggering of follicle maturation
timeFrame: Between Day 8 and Day 14
measure: Luteal phase support
timeFrame: 24-72 hours after oocyte-retrieval
Secondary outcomes:
measure: Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) in the fresh cycle
timeFrame: 10-11 weeks after embryo transfer
measure: 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
timeFrame: 10-11 weeks after embryo transfer
measure: Number of oocytes retrieved
timeFrame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) at 34-36 hours
measure: Number of oocytes/embryos/blastocysts frozen
timeFrame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
measure: Number of embryos/blastocysts transferred
timeFrame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
measure: Quality of fresh embryos or blastocysts transferred (excellent, good, fair, other)
timeFrame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
measure: Positive signs of pregnancy (clinical pregnancy)
timeFrame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 5-6 weeks after embryo transfer
measure: Positive signs of pregnancy (Positive Human chorionic gonadotropin (hCG) test or urine pregnancy test)
timeFrame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 10-11 weeks after embryo transfer
measure: Pregnancy loss in women with embryo/blastocyst transfer (biochemical pregnancy, spontaneous/elective abortion, ectopic pregnancy, vanishing twin)
timeFrame: Up to 10-11 weeks after embryo transfer
measure: Cycle cancellation before or after oocyte pick-up and reason for cycle cancellation
timeFrame: At consultation visit where cycle cancellation decided up to 10-11 weeks after embryo transfer
measure: Adverse drug reactions (ADRs)
timeFrame: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
measure: Ovarian hyperstimulation syndrome (OHSS) (including mild/moderate/severe)
timeFrame: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
measure: Preventive interventions for early OHSS
timeFrame: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
measure: Assessment of overall subject experience and convenience with REKOVELLE® by the Subject Questionnaire (assessed by the subject)
timeFrame: 34-36 hours after final injection of 1st cycle with REKOVELLE® (average 9 days)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Ferring Investigational Site
city: Horsens
country: Denmark
facility: Ferring Investigational Site
city: Køge
country: Denmark
facility: Ferring Investigational Site
city: Odense
country: Denmark
facility: Ferring Investigational Site
city: Søborg
country: Denmark
facility: Ferring Investigational Site
city: Skien
country: Norway
facility: Ferring Investigational Site
city: Malmö
country: Sweden
facility: Ferring Investigational Site
city: Baden
country: Switzerland
facility: Ferring Investigational Site
city: Basel
country: Switzerland
facility: Ferring Investigational Site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: