Ovarian StimulationPhase 4P-CCROSSNCT06175832
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
A Phase 4 study testing Elonva®, Puregon® and Orgalutran® in people with Ovarian Stimulation and Quality of Life, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
P-CCROSS is a randomized, prospective monocentric phase 4 study with a crossover study design. The aim of the study is to compare patient satisfaction (by means of questionnaires) and treatment compliance with IVF treatment with CFA (corifollitropin alfa) and PPOS (Progestin-Primed Ovarian Stimulation) versus… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Stimulation, Quality of Life, Preimplantation Genetic Testing
- What is being tested?
- Elonva®, Puregon® and Orgalutran®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Jan 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Group 1: indication for oocyte cryopreservation
- Group 2: indication for IVF/ICSI and PGT-A
- First ovarian stimulation cycle
- Aged ≥ 18 and < 41 years old at the time of first OPU
Who cannot join
- contra-indication for ovarian stimulation
- expected poor ovarian response (Bologna Criteria)
- PCOS patients
- refusal to fill out questionnaires before, during and after treatment
- simultaneous participation in another clinical study
- untreated and uncontrolled thyroid dysfunction;
- current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy;
- pregnant or breastfeeding women. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, 9000
Dominic Stoop, Prof. dr., Dominic.Stoop@uzgent.be
Kathleen Wijnant, Msc, Kathleen.Wijnant@uzgent.be
About this study
Official title: PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study
P-CCROSS is a randomized, prospective monocentric phase 4 study with a crossover study design. The aim of the study is to compare patient satisfaction (by means of questionnaires) and treatment compliance with IVF treatment with CFA (corifollitropin alfa) and PPOS (Progestin-Primed Ovarian Stimulation) versus conventional IVF treatment with a recombinant FSH/GnRH antagonist. The study will also compare patients undergoing elective fertility preservation versus PGT-A (pre-implantation genetic testing for aneuploidy) patients.The study will have a crossover design so that patients will receive both forms of treatment. The investigators will also compare the endocrine profile and ovarian response of CFA/PPOS versus rFSH/GnRH ovarian stimulation cycles.
- Conditions
- Ovarian Stimulation, Quality of Life, Preimplantation Genetic Testing, Fertility Preservation
- Being tested
- Elonva®, Puregon®, Orgalutran®, Gonapeptyl®, Cerazette®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elonva®Drug
Single injection
Puregon®Drug
Multiple injections
Orgalutran®Drug
Multiple injections
Gonapeptyl®Drug
Double injection
Cerazette®Drug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| CFA/PPOS cycle | Experimental | Interventional stimulation Receives: Drug: Elonva®; Drug: Puregon®; Drug: Gonapeptyl®; Drug: Cerazette® |
| rFSH / GnRH antagonist cycle | Active comparator | Conventional stimulation Receives: Drug: Puregon®; Drug: Orgalutran®; Drug: Gonapeptyl® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles
Comparison of CFA / PPOS stimulation versus conventional rFSH / GnRH antagonist ovarian stimulation cycles with respect to mean treatment-related quality of life and patient satisfaction. Treatment-related quality of life and patient satisfaction retrieved from the second questionnaire (Q2), which is completed at the end of each stimulation cycle; after the agonist trigger and before the oocyte retrieval.Q2 is a combination of the treatment module of the validated FertiQoL questionnaire and the EFESO questionnaire. This questionnaire will assess the environment and tolerability of the fertility treatment.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start27 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian StimulationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175832
- Sponsor's protocol ID
- ONZ-2023-0299
- Other IDs
- 2023-506694-35-00, 2023
- Acronym
- P-CCROSS
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study
- ClinicalTrials.gov ID
- NCT06175832
- Acronym / sponsor ID
- P-CCROSS / ONZ-2023-0299
- Conditions
- Ovarian Stimulation, Quality of Life, Preimplantation Genetic Testing, Fertility Preservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Organon
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
P-CCROSS is a randomized, prospective monocentric phase 4 study with a crossover study design. The aim of the study is to compare patient satisfaction (by means of questionnaires) and treatment compliance with IVF treatment with CFA (corifollitropin alfa) and PPOS (Progestin-Primed Ovarian Stimulation) versus conventional IVF treatment with a recombinant FSH/GnRH antagonist. The study will also compare patients undergoing elective fertility preservation versus PGT-A (pre-implantation genetic testing for aneuploidy) patients.The study will have a crossover design so that patients will receive both forms of treatment. The investigators will also compare the endocrine profile and ovarian response of CFA/PPOS versus rFSH/GnRH ovarian stimulation cycles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFA/PPOS cycle | Experimental | Drug: Elonva®, Drug: Puregon®, Drug: Gonapeptyl®, Drug: Cerazette®Interventional stimulation |
| rFSH / GnRH antagonist cycle | Active comparator | Drug: Puregon®, Drug: Orgalutran®, Drug: Gonapeptyl®Conventional stimulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Group 1: indication for oocyte cryopreservation
- Group 2: indication for IVF/ICSI and PGT-A
- First ovarian stimulation cycle
- Aged ≥ 18 and < 41 years old at the time of first OPU
Key exclusion criteria (8 listed)
- contra-indication for ovarian stimulation
- expected poor ovarian response (Bologna Criteria)
- PCOS patients
- refusal to fill out questionnaires before, during and after treatment
- simultaneous participation in another clinical study
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 |
|---|---|---|
| Elonva®Single injection | Drug | CFA/PPOS cycle |
| Puregon®Multiple injections | Drug | CFA/PPOS cycle, rFSH / GnRH antagonist cycle |
| Orgalutran®Multiple injections | Drug | rFSH / GnRH antagonist cycle |
| Gonapeptyl®Double injection | Drug | CFA/PPOS cycle, rFSH / GnRH antagonist cycle |
| Cerazette®Oral tablet | Drug | CFA/PPOS cycle |
Primary outcome
Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles
Time frame: Six months
Comparison of CFA / PPOS stimulation versus conventional rFSH / GnRH antagonist ovarian stimulation cycles with respect to mean treatment-related quality of life and patient satisfaction. Treatment-related quality of life and patient satisfaction retrieved from the second questionnaire (Q2), which is completed at the end of each stimulation cycle; after the agonist trigger and before the oocyte retrieval.Q2 is a combination of the treatment module of the validated FertiQoL questionnaire and the EFESO questionnaire. This questionnaire will assess the environment and tolerability of the fertility treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elonva®, Puregon® and Orgalutran® in people with Ovarian Stimulation and Quality of Life, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominic Stoop, Prof. dr. (093321699, Dominic.Stoop@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.