MedTrace Logo

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

NCT05263388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2025-04-02

Study results available
· View outcomes & findings →

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.

Conditions

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.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2024-04-16
Completion
2024-04-16

Countries

  • Austria
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05263388 on ClinicalTrials.gov