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

RecruitingPhase 4Ages 18 Years - 40 YearsFemaleUniversity Hospital, Ghent
NCT06175832 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Elonva®
  • Puregon®
  • Orgalutran®
  • Gonapeptyl®
  • Cerazette®
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Where

1 site
University Hospital Ghent
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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