Progestin-primed ovarian stimulation with corifollitropin alfa versus standard rFSH/GnRH antagonist (crossover)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

P-CCROSS is a randomized, prospective monocentric phase 4 crossover trial comparing PPOS with corifollitropin alfa to conventional rFSH plus a GnRH antagonist. Eligible participants are women aged 18–40 undergoing their first ovarian stimulation for elective oocyte cryopreservation or for IVF/ICSI with PGT‑A, and each participant will receive both stimulation regimens in separate cycles. The study uses patient questionnaires to measure satisfaction and treatment compliance and also compares endocrine profiles and ovarian response metrics between cycles. Treatments are provided at University Hospital Ghent using commonly used medications such as Elonva®, Puregon®, Orgalutran®, Gonapeptyl®, and Cerazette®.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital Ghent
  Ghent, Belgium Recruiting

Study contacts

• Study coordinator: Dominic Stoop, Prof. dr.
• Email: Dominic.Stoop@uzgent.be
• Phone: 093321699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.