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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175832
• Other study ID #: 2023-506694-35-00
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: May 10, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fertility Preservation
• Ovarian Stimulation
• Preimplantation Genetic Testing
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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