Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures (PROFILE)

Ferring

Status: Completed

Conditions: Controlled Ovarian Stimulation

Treatments: Drug: Follitropin Delta

Study type: Observational

Funder types: Industry

Identifiers

NCT03393780

000300

Details and patient eligibility

About

The purpose of this study is to monitor the use in routine clinical practice of REKOVELLE®. This study will collect information from patients who never underwent previous in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatments for up to three consecutive treatment cycles.

The ovarian stimulation protocol with REKOVELLE®, a new recombinant human Follicle Stimulating Hormone (FSH) prescribed for ovarian stimulation, is individualised with a dosing regimen that is based on two parameters: the body weight and the level of a hormone, the Anti Müllerian Hormone, (AMH), a parameter used to predict how the ovaries will respond to the ovarian stimulation.

Enrollment: 1,018 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients who meet all of the following criteria are eligible for participation:

• Females are prescribed REKOVELLE® for their first in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor
• Willing and able to provide written informed consent

Exclusion Criteria: Patients who meet any of the following criteria are not eligible for participation:

• 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