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

NCT ID: NCT06175832

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Ovarian Stimulation Quality of Life Preimplantation Genetic Testing Fertility Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CFA/PPOS cycle

Interventional stimulation

Group Type EXPERIMENTAL

Elonva®

Intervention Type DRUG

Single injection

Puregon®

Intervention Type DRUG

Multiple injections

Gonapeptyl®

Intervention Type DRUG

Double injection

Cerazette®

Intervention Type DRUG

Oral tablet

rFSH / GnRH antagonist cycle

Conventional stimulation

Group Type ACTIVE_COMPARATOR

Puregon®

Intervention Type DRUG

Multiple injections

Orgalutran®

Intervention Type DRUG

Multiple injections

Gonapeptyl®

Intervention Type DRUG

Double injection

Interventions

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Elonva®

Single injection

Intervention Type DRUG

Puregon®

Multiple injections

Intervention Type DRUG

Orgalutran®

Multiple injections

Intervention Type DRUG

Gonapeptyl®

Double injection

Intervention Type DRUG

Cerazette®

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Group 1: indication for oocyte cryopreservation
* Group 2: indication for IVF/ICSI and PGT-A


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Organon

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Dominic Stoop, Prof. dr.

Role: CONTACT

Phone: 093321699

Email: [email protected]

Kathleen Wijnant, Msc

Role: CONTACT

Phone: +32(0)93323013

Email: [email protected]

Facility Contacts

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Dominic Stoop, Prof. dr.

Role: primary

Kathleen Wijnant, Msc

Role: backup

Other Identifiers

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2023-506694-35-00

Identifier Type: CTIS

Identifier Source: secondary_id

ONZ-2023-0299

Identifier Type: -

Identifier Source: org_study_id