A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
NCT ID: NCT05263388
Last Updated: 2025-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
302 participants
INTERVENTIONAL
2022-07-15
2024-04-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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REKOVELLE (Follitropin Delta)
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.
GONAL-F (Follitropin Alfa)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Ferring Investigational Site
Wals-Seizenheim, Salzburg, Austria
Ferring Investigational Site
Vienna, , Austria
Ferring Investigational Site
Montpellier, , France
Ferring Investigational Site
Paris, , France
Ferring Investigational Site
Florence, , Italy
Ferring Investigational Site
Milan, , Italy
Ferring Investigational Site
Napoli, , Italy
Ferring Investigational Site
Roma, , Italy
Ferring Investigational Site
Alicante, , Spain
Ferring Investigational Site
Barcelona, , Spain
Ferring Investigational Site
Bilbao, , Spain
Ferring Investigational Site
Madrid, , Spain
Ferring Investigational Site
Málaga, , Spain
Ferring Investigational Site
Valladolid, , Spain
Ferring Investigational Site
Coventry, , United Kingdom
Ferring Investigational Site
Liverpool, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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U1111-1267-1119
Identifier Type: OTHER
Identifier Source: secondary_id
000401
Identifier Type: -
Identifier Source: org_study_id
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