Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice (DELTA)

Ferring

Status: Completed

Conditions: Controlled Ovarian Stimulation

Treatments: Drug: Follitropin Delta

Study type: Observational

Funder types: Industry

Identifiers

NCT04503707

000370

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Follitropin Delta

Description:

Treatment according to routine clinical practice.

Treatment:

Drug: Follitropin Delta