Ovarian Stimulation, Quality of Life, Preimplantation Genetic Testing, Fertility Preservation
Conditions
Brief summary
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
DRUGElonva®
Single injection
DRUGPuregon®
Multiple injections
DRUGOrgalutran®
Multiple injections
DRUGGonapeptyl®
Double injection
DRUGCerazette®
Oral tablet
Sponsors
Organon
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles | Six months | 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. |
Countries
Belgium
Contacts
Primary ContactDominic Stoop, Prof. dr.
Backup ContactKathleen Wijnant, Msc
Outcome results
None listed