A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation

Last updated: March 13, 2025
Sponsor: Ferring Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Infertility

Treatment

GONAL-F (Follitropin Alfa)

REKOVELLE (Follitropin Delta)

Clinical Study ID

NCT05263388
000401
U1111-1267-1119
  • Ages 18-40
  • Female

Study Summary

Hormone preparations like REKOVELLE and GONAL-F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment.

The main purpose of this trial is to see how many eggs are produced with a starting dose of 15 µg REKOVELLE compared to a starting dose of 225 IU GONAL-F. This research is intended to provide more knowledge about REKOVELLE, including the doses given in the trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infertile women aged 18-40 years

  • Diagnosed with tubal infertility, unexplained infertility, mild endometriosis (stageI/II) or partners with decreased sperm quality

  • Medically eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperminjection (ICSI)

  • Infertility for at least one year for participants ≤ 37 years or for at least 6months for participants ≥ 38 years

  • Regular menstrual cycles of 21-35 days.

Exclusion

Exclusion Criteria:

  • Known condition of not functioning ovaries

  • Known advanced endometriosis (stage III/IV)

  • Considered unsuitable for controlled ovarian stimulation with a dosing regimencorresponding to approximately 225 IU/day gonadotropin, as judged by theinvestigator

  • History of previous episode of OHSS or exuberant ovarian response to gonadotropins,and polycystic ovarian syndrome

  • Any known hormonal or metabolic abnormalities which can compromise participation inthe trial

  • Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus

Study Design

Total Participants: 302
Treatment Group(s): 2
Primary Treatment: GONAL-F (Follitropin Alfa)
Phase: 3
Study Start date:
July 15, 2022
Estimated Completion Date:
April 16, 2024

Connect with a study center

  • Ferring Investigational Site

    Wals-Seizenheim, Salzburg
    Austria

    Site Not Available

  • Ferring Investigational Site

    Wals-Siezenheim,
    Austria

    Site Not Available

  • Ferring Investigational Site

    Wien,
    Austria

    Site Not Available

  • Ferring Investigational Site

    Montpellier,
    France

    Site Not Available

  • Ferring Investigational Site

    Paris,
    France

    Site Not Available

  • Ferring Investigational Site

    Firenze,
    Italy

    Site Not Available

  • Ferring Investigational Site

    Milano,
    Italy

    Site Not Available

  • Ferring Investigational Site

    Napoli,
    Italy

    Site Not Available

  • Ferring Investigational Site

    Roma,
    Italy

    Site Not Available

  • Ferring Investigational Site

    Alicante,
    Spain

    Site Not Available

  • Ferring Investigational Site

    Barcelona,
    Spain

    Site Not Available

  • Ferring Investigational Site

    Bilbao,
    Spain

    Site Not Available

  • Ferring Investigational Site

    Madrid,
    Spain

    Site Not Available

  • Ferring Investigational Site

    Malaga,
    Spain

    Site Not Available

  • Ferring Investigational Site

    Valladolid,
    Spain

    Site Not Available

  • Ferring Investigational Site

    Coventry,
    United Kingdom

    Site Not Available

  • Ferring Investigational Site

    Liverpool,
    United Kingdom

    Site Not Available

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