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 (NORSOS)

Ferring

Status: Completed

Conditions: Controlled Ovarian Stimulation

Treatments: Drug: REKOVELLE®

Study type: Observational

Funder types: Industry

Identifiers

NCT05499052

000411

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

201 participants in 1 patient group

REKOVELLE®

Treatment:

Drug: REKOVELLE®