PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elonva®, Puregon®, Orgalutran®, Gonapeptyl®.
- Who it may be relevant to
- Registry conditions: Ovarian Stimulation, Quality of Life, Preimplantation Genetic Testing, Fertility Preservation. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study
Overview
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.
Interventions
- Drug Elonva®
Single injection - Drug Puregon®
Multiple injections - Drug Orgalutran®
Multiple injections - Drug Gonapeptyl®
Double injection - Drug Cerazette®
Oral tablet
Primary outcome measures
- Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles [Time frame: Six months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Belgium · 1 center
- University Hospital Ghent — Ghent
Identifiers
NCT: NCT06175832 · ONZ-2023-0299 · 2023-506694-35-00