NCT06175832 PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
| NCT ID | NCT06175832 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Ghent |
| Condition | Ovarian Stimulation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-01-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Prescreening: Clarification: Pre-screening might be performed to identify women with AFC \> 5 and AMH \> 1.1 ng/ml (Bologna criteria, AFC and AMH values are valid for one year). Inclusion criteria for: * Group 1: indication for oocyte cryopreservation * Group 2: indication for IVF/ICSI and PGT-A Inclusion criteria for both groups: * First ovarian stimulation cycle * Aged ≥ 18 and \< 41 years old at the time of first OPU Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06175832 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Ovarian Stimulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06175832 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06175832 currently recruiting?
Yes, NCT06175832 is actively recruiting participants. Contact the research team at Dominic.Stoop@uzgent.be for enrollment information.
Where is the NCT06175832 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06175832 clinical trial?
NCT06175832 is sponsored by University Hospital, Ghent. The trial plans to enroll 60 participants.