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

Phase 4

Not yet recruiting

• Conditions: Ovarian Stimulation; Quality of Life; Preimplantation Genetic Testing; Fertility Preservation
• Interventions: Drug: Elonva®; Drug: Orgalutran®; Drug: Puregon®; Drug: Gonapeptyl®; Drug: Cerazette®

• Registration Number: NCT06175832
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Study Start: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-05-10
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• first ovarian stimulation cycle
• aged ≥ 18 and < 41 years old at the time of first OPU
• Body Mass Index (BMI) ≥ 18 kg/m² and < 32 kg/m²

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CFA/PPOS cycle	Elonva®	Interventional stimulation
rFSH / GnRH antagonist cycle	Orgalutran®	Conventional stimulation
CFA/PPOS cycle	Puregon®	Interventional stimulation
CFA/PPOS cycle	Gonapeptyl®	Interventional stimulation
CFA/PPOS cycle	Cerazette®	Interventional stimulation
rFSH / GnRH antagonist cycle	Gonapeptyl®	Conventional stimulation
rFSH / GnRH antagonist cycle	Puregon®	Conventional stimulation

Primary Outcome Measures

Name	Time	Method
Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles	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.