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

Study Overview
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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.

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

Conditions
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Ovarian Stimulation, Quality of Life, Preimplantation Genetic Testing, Fertility Preservation

Intervention / Treatment
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* Drug: Elonva®
* Drug: Puregon®
* Drug: Orgalutran®
* Drug: Gonapeptyl®
* Drug: Cerazette®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first ovarian stimulation cycle aged ≥ 18 and < 41 years old at the time of first OPU Body Mass Index (BMI) ≥ 18 kg/m² and < 32 kg/m² 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CFA/PPOS cycle<br>Interventional stimulation | Drug: Elonva®<br>* Single injection<br>Drug: Puregon®<br>* Multiple injections<br>Drug: Gonapeptyl®<br>* Double injection<br>Drug: Cerazette®<br>* Oral tablet<br>|
| Active Comparator: rFSH / GnRH antagonist cycle<br>Conventional stimulation | Drug: Puregon®<br>* Multiple injections<br>Drug: Orgalutran®<br>* Multiple injections<br>Drug: Gonapeptyl®<br>* Double injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles | 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. | Six months |