Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings (PROFOUND)

Ferring

Status: Enrolling

Conditions: Infertility

Treatments: Drug: REKOVELLE

Study type: Observational

Funder types: Industry

Identifiers

NCT06561958

000430

Details and patient eligibility

About

Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females aged 20 years or older at enrollment
• Serum AMH level >0.5 ng / mL (with the latest result tested within 12 months)
• Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable)
• Willing and able to provide written informed consent

Exclusion criteria

• Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment
• Participating in an interventional clinical trial in which any medication treatment is mandated
• Women with a contraindication for prescription of REKOVELLE treatment
• Oocyte donors
• Undergoing ovarian stimulation for fertility preservation

Trial design

1,500 participants in 1 patient group

REKOVELLE

Description:

Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation.

Treatment:

Drug: REKOVELLE