PPOS (Progestin primed ovarian stimulation) and Corifollitropin alfa (CFA) cross-over study

Phase 1

• Conditions: Subfertility; Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

• Registration Number: CTIS2023-506694-35-00
• Lead Sponsor: niversitair Ziekenhuis Gent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Group 1: indication for oocyte cryopreservation, Group 2: indication for IVF/ICSI and PGT-A, for both groups: First ovarian stimulation cycle, for both groups: Aged = 18 and < 41 years old at the time of first OPU, for both groups: 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare CFA / PPOS stimulation versus conventional rFSH / GnRH antagonist ovarian<br>stimulation cycles with respect to mean treatment-related quality of life and patient satisfaction<br>in both subjects undergoing elective fertility preservation and subjects undergoing PGT.;Secondary Objective: To evaluate if the effect of treatment regimen on mean treatment-related quality of life and patient satisfaction is different between subjects undergoing elective fertility preservation and subjects undergoing PGT treatment. Thus testing for effect modification of the treatment by indication for the treatment (preventive against therapeutic).;Primary end point(s): 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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Patient feedback derived from the third questionnaire (Q3), which is completed within 3 weeks after completing the second stimulation cycle.