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

PHASE3CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

July 15, 2022

Primary Completion Date

April 16, 2024

Study Completion Date

April 16, 2024

Conditions
Infertility
Interventions
DRUG

REKOVELLE (Follitropin Delta)

REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the participant's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Participants could be treated for a maximum of 20 days.

OTHER

GONAL-F (Follitropin Alfa)

GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the participant's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Participants could be treated for a maximum of 20 days.

Trial Locations (16)

Unknown

Ferring Investigational Site, Wals-Seizenheim

Ferring Investigational Site, Vienna

Ferring Investigational Site, Montpellier

Ferring Investigational Site, Paris

Ferring Investigational Site, Florence

Ferring Investigational Site, Milan

Ferring Investigational Site, Napoli

Ferring Investigational Site, Roma

Ferring Investigational Site, Alicante

Ferring Investigational Site, Barcelona

Ferring Investigational Site, Bilbao

Ferring Investigational Site, Madrid

Ferring Investigational Site, Málaga

Ferring Investigational Site, Valladolid

Ferring Investigational Site, Coventry

Ferring Investigational Site, Liverpool

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY

NCT05263388 - A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation | Biotech Hunter | Biotech Hunter