Progestin-primed ovarian stimulation with corifollitropin alfa versus standard rFSH/GnRH antagonist (crossover)

PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study

This study will test whether progestin-primed ovarian stimulation using a single-dose corifollitropin alfa improves patient satisfaction and compliance while producing similar ovarian response compared with conventional recombinant FSH plus a GnRH antagonist in women having their first IVF/ICSI cycle for fertility preservation or PGT‑A.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: University Hospital, Ghent (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Ghent)
• Trial ID: NCT06175832 on ClinicalTrials.gov

What this trial studies

P-CCROSS is a randomized, prospective monocentric phase 4 crossover trial comparing PPOS with corifollitropin alfa to conventional rFSH plus a GnRH antagonist. Eligible participants are women aged 18–40 undergoing their first ovarian stimulation for elective oocyte cryopreservation or for IVF/ICSI with PGT‑A, and each participant will receive both stimulation regimens in separate cycles. The study uses patient questionnaires to measure satisfaction and treatment compliance and also compares endocrine profiles and ovarian response metrics between cycles. Treatments are provided at University Hospital Ghent using commonly used medications such as Elonva®, Puregon®, Orgalutran®, Gonapeptyl®, and Cerazette®.

Who should consider this trial

Good fit: Women aged 18–40 having their first ovarian stimulation for elective oocyte cryopreservation or for IVF/ICSI with PGT‑A who meet pre-screening ovarian reserve criteria (AFC > 5 and AMH > 1.1 ng/ml) are ideal candidates.

Not a fit: Patients with expected poor ovarian response (Bologna criteria), PCOS, contraindications to ovarian stimulation, uncontrolled thyroid disease, current pregnancy or breastfeeding, or those taking excluded medications are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could make stimulation simpler and more comfortable for patients while maintaining ovarian response and oocyte yield.

How similar studies have performed: Previous studies indicate PPOS and corifollitropin alfa can effectively stimulate the ovaries and simplify dosing, but randomized crossover comparisons that focus on patient satisfaction are limited.

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.

Where this trial is running

Ghent

• University Hospital Ghent — Ghent, Belgium (Recruiting)

Study contacts

• Study coordinator: Dominic Stoop, Prof. dr.

Conditions Ovarian Stimulation; Quality of Life; Preimplantation Genetic Testing; Fertility Preservation