NCT05263388

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2022

Geographic Reach
5 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

April 2, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

November 16, 2021

Results QC Date

March 13, 2025

Last Update Submit

March 13, 2025

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of Oocytes Retrieved

    The number of oocytes retrieved was recorded at the oocyte retrieval visit.

    On day of oocyte retrieval (Up to 22 days after start of stimulation)

Secondary Outcomes (10)

  • Number of Follicles (Total) at End-of-stimulation

    At end-of-stimulation (up to 20 stimulation days)

  • Size of the Follicles at End-of-stimulation

    At end-of-stimulation (up to 20 stimulation days)

  • Serum Concentrations of Estradiol at End-of-stimulation

    At end-of-stimulation (up to 20 stimulation days)

  • Serum Concentrations of Progesterone at End-of-stimulation

    At end-of-stimulation (up to 20 stimulation days)

  • Number of Fertilized Oocytes

    On day 1 after oocyte retrieval (up to 23 days after start of stimulation)

  • +5 more secondary outcomes

Study Arms (2)

REKOVELLE (Follitropin Delta)

EXPERIMENTAL
Drug: REKOVELLE (Follitropin Delta)

GONAL-F (Follitropin Alfa)

ACTIVE COMPARATOR
Other: GONAL-F (Follitropin Alfa)

Interventions

REKOVELLE (Follitropin Delta)DRUG

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.

REKOVELLE (Follitropin Delta)
GONAL-F (Follitropin Alfa)OTHER

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.

GONAL-F (Follitropin Alfa)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Regular menstrual cycles of 21-35 days.

You may not qualify if:

  • 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
  • Any known hormonal or metabolic abnormalities which can compromise participation in the trial
  • Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Ferring Investigational Site

Wals-Seizenheim, Salzburg, Austria

Location

Ferring Investigational Site

Vienna, Austria

Location

Ferring Investigational Site

Montpellier, France

Location

Ferring Investigational Site

Paris, France

Location

Ferring Investigational Site

Florence, Italy

Location

Ferring Investigational Site

Milan, Italy

Location

Ferring Investigational Site

Napoli, Italy

Location

Ferring Investigational Site

Roma, Italy

Location

Ferring Investigational Site

Alicante, Spain

Location

Ferring Investigational Site

Barcelona, Spain

Location

Ferring Investigational Site

Bilbao, Spain

Location

Ferring Investigational Site

Madrid, Spain

Location

Ferring Investigational Site

Málaga, Spain

Location

Ferring Investigational Site

Valladolid, Spain

Location

Ferring Investigational Site

Coventry, United Kingdom

Location

Ferring Investigational Site

Liverpool, United Kingdom

Location

Related Publications (1)

  • Bernabeu A, Zajc P, Garcia Sanchez M, Agrawal R, Papaleo E, Jirecek S, Mogelmose S, Jepsen IE, Lobo R. Ovarian stimulation with follitropin delta for in vitro fertilization: a multicentre, randomized, assessor-blind comparison with follitropin alfa using conventional dosing regimens (ADAPT-1 trial). Hum Reprod. 2025 Sep 1;40(9):1660-1670. doi: 10.1093/humrep/deaf119.

    PMID: 40633120DERIVED

MeSH Terms

Conditions

Infertility

Interventions

follitropin deltafollitropin alfa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Results Point of Contact

Title
Global Clinical Compliance
Organization
Ferring Pharmaceuticals
Disclosure@ferring.com
+1 862-286-5200

Study Officials

  • Global Clinical Compliance

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

March 2, 2022

Study Start

July 15, 2022

Primary Completion

April 16, 2024

Study Completion

April 16, 2024

Last Updated

April 2, 2025

Results First Posted

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)GB(2)IT(4)AU(2)ES(6)