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NCT Number: NCT06175832

PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) 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.

Recruiting

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Dominic Stoop, Prof. dr.

CONTACT

[email protected]

Kathleen Wijnant, Msc

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elonva®

Drug

Single injection

Puregon®

Drug

Multiple injections

Orgalutran®

Drug

Multiple injections

Gonapeptyl®

Drug

Double injection

Cerazette®

Drug

Oral tablet

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominic Stoop, Prof. dr.

CONTACT

[email protected]

093321699

Kathleen Wijnant, Msc

CONTACT

[email protected]

+32(0)93323013

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Organon

Registry information

Official study title

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

Acronym: P-CCROSS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2023
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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