Completed

ADAPT-1A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Ovarian Response of a Starting Dose of 15 μg Follitropin Delta (REKOVELLE) to a Starting Dose of 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

What is being tested

REKOVELLE (Follitropin Delta)

+ GONAL-F (Follitropin Alfa)

DrugOther

Who is being recruted

Urogenital Diseases

+ Genital Diseases

+ Infertility

From 18 to 40 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: July 2022

See protocol details

Summary

Principal SponsorFerring Pharmaceuticals

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 15, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleA Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Ovarian Response of a Starting Dose of 15 μg Follitropin Delta (REKOVELLE) to a Starting Dose of 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

NCT05263388

Principal SponsorFerring Pharmaceuticals

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

302 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesInfertility

Criteria

5 inclusion criteria required to participate

Infertile women aged 18-40 years

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

Medically eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI)

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

Show More Criteria

6 exclusion criteria prevent from participating

Known condition of not functioning ovaries

Known advanced endometriosis (stage III/IV)

Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 16 locations

Suspended

Ferring Investigational Site

Madrid, SpainOpen Ferring Investigational Site in Google Maps

Suspended

Ferring Investigational Site

Wals-Seizenheim, Austria

Suspended

Ferring Investigational Site

Vienna, Austria

Suspended

Ferring Investigational Site

Montpellier, France

Completed16 Study Centers