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

Last updated: January 21, 2025
Sponsor: Ferring Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

REKOVELLE

Clinical Study ID

NCT06561958
000430
  • Ages > 20
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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 orICSI treatment cycle using fresh or frozen ejaculated sperm from male partner orsperm donor (if applicable)

  • Willing and able to provide written informed consent

Exclusion

Exclusion Criteria:

  • Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment

  • Participating in an interventional clinical trial in which any medication treatmentis mandated

  • Women with a contraindication for prescription of REKOVELLE treatment

  • Oocyte donors

  • Undergoing ovarian stimulation for fertility preservation

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: REKOVELLE
Phase:
Study Start date:
August 27, 2024
Estimated Completion Date:
August 01, 2027

Connect with a study center

  • Ferring Investigational Site

    Kitakyushu, Fukuoka 8070825
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Takasaki, Gunma 3700841
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Bunkyō-Ku, 1130033
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Chiba, 2610023
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Fukuoka, 8120013
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Hiroshima, 7300035
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Hokkaido, 0600003
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Hyōgo, 6500021
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Osaka, 5300011
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Saitama, 3540035
    Japan

    Active - Recruiting

  • Ferring Investigational Site

    Tokyo, 1600023
    Japan

    Active - Recruiting

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