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

ConditionsOvarian Stimulation Quality of Life Preimplantation Genetic Testing Fertility Preservation

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18-40

SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Group 1: indication for oocyte cryopreservation

Group 2: indication for IVF/ICSI and PGT-A

First ovarian stimulation cycle

Aged ≥ 18 and < 41 years old at the time of first OPU

Disqualifiers

contra-indication for ovarian stimulation

expected poor ovarian response (Bologna Criteria)

PCOS patients

refusal to fill out questionnaires before, during and after treatment

Trial design

Design model

Crossover

Treatments tested in this trial

Elonva®
Drug
Single injection
Puregon®
Drug
Multiple injections
Orgalutran®
Drug
Multiple injections
Gonapeptyl®
Drug
Double injection
Cerazette®
Drug
Oral tablet

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: CFA/PPOS cycleExperimental treatment 4 interventions

Group B: rFSH / GnRH antagonist cycleActive comparator 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Six months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Organon

Collaborator

Source ClinicalTrials.gov

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