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

Ghent University Hospital (UZ)

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Gonapeptyl®; Drug: Orgalutran®; Drug: Puregon®; Drug: Elonva®; Drug: Cerazette®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06175832

ONZ-2023-0299

2023-506694-35-00

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

CFA/PPOS cycle

Experimental group

Description:

Interventional stimulation

Treatment:

Drug: Cerazette®

Drug: Elonva®

Drug: Puregon®

Drug: Gonapeptyl®

rFSH / GnRH antagonist cycle

Active Comparator group

Description:

Conventional stimulation

Treatment:

Drug: Puregon®

Drug: Orgalutran®

Drug: Gonapeptyl®