PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study (P-CCROSS)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Ovarian Stimulation; Preimplantation Genetic Testing; Fertility Preservation
• Intervention / Treatment: Drug: Elonva®; Drug: Puregon®; Drug: Gonapeptyl®; Drug: Cerazette®; Drug: Orgalutran®

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dominic Stoop, Prof. dr.; Phone Number: 093321699; Email: Dominic.Stoop@uzgent.be
• Study Contact Backup: Name: Kathleen Wijnant, Msc; Phone Number: +32(0)93323013; Email: Kathleen.Wijnant@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • University Hospital Ghent
    • Contact: Dominic Stoop, Prof. dr.; Email: Dominic.Stoop@uzgent.be
    • Contact: Kathleen Wijnant, Msc; Email: Kathleen.Wijnant@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CFA/PPOS cycle; Interventional stimulation	Drug: Elonva®; Single injection; Drug: Puregon®; Multiple injections; Drug: Gonapeptyl®; Double injection; Drug: Cerazette®; Oral tablet
Active Comparator: rFSH / GnRH antagonist cycle; Conventional stimulation	Drug: Puregon®; Multiple injections; Drug: Gonapeptyl®; Double injection; Drug: Orgalutran®; Multiple injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Organon

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Polycyclic Compounds; Steroids; Fused-Ring Compounds; Norpregnenes; Norpregnanes; Norsteroids; Desogestrel; ganirelix; follitropin beta
• Other Study ID Numbers: ONZ-2023-0299; 2023-506694-35-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No