InfertilityPhase 3ADAPT-1NCT05263388
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
A Phase 3 study testing REKOVELLE (Follitropin Delta) and GONAL-F (Follitropin Alfa) in people with Infertility, run by Ferring Pharmaceuticals at 16 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- REKOVELLE (Follitropin Delta) and GONAL-F (Follitropin Alfa)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 15 Jul 2022to 16 Apr 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Spain6 sites
Ferring Investigational Site
Alicante
Ferring Investigational Site
Barcelona
Ferring Investigational Site
Bilbao
Ferring Investigational Site
Madrid
Ferring Investigational Site
Málaga
Ferring Investigational Site
Valladolid
Italy4 sites
Ferring Investigational Site
Florence
Ferring Investigational Site
Milan
Ferring Investigational Site
Naples
Ferring Investigational Site
Roma
Austria2 sites
Ferring Investigational Site
Vienna
Ferring Investigational Site
Wals-Seizenheim, State of Salzburg
France2 sites
Ferring Investigational Site
Montpellier
Ferring Investigational Site
Paris
United Kingdom2 sites
Ferring Investigational Site
Coventry
Ferring Investigational Site
Liverpool
About this study
Official title: A 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
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
- Infertility
- Being tested
- REKOVELLE (Follitropin Delta), GONAL-F (Follitropin Alfa)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| REKOVELLE (Follitropin Delta) | Experimental | Not described Receives: Drug: REKOVELLE (Follitropin Delta) |
| GONAL-F (Follitropin Alfa) | Active comparator | Not described Receives: Other: GONAL-F (Follitropin Alfa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
Measured: On day of oocyte retrieval (Up to 22 days after start of stimulation)
Secondary outcomes (10)
Number of Follicles (Total) at End-of-stimulation
Counted by transvaginal ultrasound for the right and left ovary for each subject.
Measured: At end-of-stimulation (up to 20 stimulation days)
Size of the Follicles at End-of-stimulation
Counted by ultrasound for the right and left ovary for each subject.
Measured: At end-of-stimulation (up to 20 stimulation days)
Serum Concentrations of Estradiol at End-of-stimulation
Blood samples for analysis of circulating concentrations of estradiol were drawn.
Measured: At end-of-stimulation (up to 20 stimulation days)
Serum Concentrations of Progesterone at End-of-stimulation
Blood samples for analysis of circulating concentrations of progesterone were drawn.
Measured: At end-of-stimulation (up to 20 stimulation days)
Number of Fertilized Oocytes
The number of pronuclei were counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) were regarded as correctly fertilized.
Measured: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Fertilization Rate
The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved.
Measured: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Number of Blastocysts and Number of Good Quality Blastocysts
Number of blastocysts and number of good quality blastocysts on Day 5 or 6 were presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner \& Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.
Measured: On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation)
Total Gonadotropin Dose
Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP).
Measured: Up to 20 stimulation days
Number of Stimulation Days
Calculated by start dates and end dates.
Measured: Up to 20 stimulation days
Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS
Early OHSS is defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.
Measured: Up to 9 days after triggering of final follicular maturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Jul 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263388
- Sponsor's protocol ID
- 000401
- Other IDs
- U1111-1267-1119
- Acronym
- ADAPT-1
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2021
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40633120
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT05263388
- Acronym / sponsor ID
- ADAPT-1 / 000401
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REKOVELLE (Follitropin Delta) | Experimental | Drug: REKOVELLE (Follitropin Delta) |
| GONAL-F (Follitropin Alfa) | Active comparator | Other: GONAL-F (Follitropin Alfa) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | REKOVELLE (Follitropin Delta) |
| 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. | Other | GONAL-F (Follitropin Alfa) |
Primary outcome
Number of Oocytes Retrieved
Time frame: On day of oocyte retrieval (Up to 22 days after start of stimulation)
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
10 secondary outcomes
Number of Follicles (Total) at End-of-stimulation
Time frame: At end-of-stimulation (up to 20 stimulation days)
Size of the Follicles at End-of-stimulation
Time frame: At end-of-stimulation (up to 20 stimulation days)
Serum Concentrations of Estradiol at End-of-stimulation
Time frame: At end-of-stimulation (up to 20 stimulation days)
Serum Concentrations of Progesterone at End-of-stimulation
Time frame: At end-of-stimulation (up to 20 stimulation days)
Number of Fertilized Oocytes
Time frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Fertilization Rate
Time frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Number of Blastocysts and Number of Good Quality Blastocysts
Time frame: On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation)
Total Gonadotropin Dose
Time frame: Up to 20 stimulation days
Number of Stimulation Days
Time frame: Up to 20 stimulation days
Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS
Time frame: Up to 9 days after triggering of final follicular maturation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40633120Bernabeu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REKOVELLE (Follitropin Delta) and GONAL-F (Follitropin Alfa) in people with Infertility, run by Ferring Pharmaceuticals at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, Italy, Austria, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Oocytes Retrieved (time frame: On day of oocyte retrieval (Up to 22 days after start of stimulation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05263388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.