NCT06175832

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
20mo left

Started Jan 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

November 28, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

November 28, 2023

Last Update Submit

December 18, 2025

Conditions

Quality of LifePreimplantation Genetic TestingFertility PreservationOvarian Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CFA/PPOS cycle

EXPERIMENTAL

Interventional stimulation

Drug: Elonva®Drug: Puregon®Drug: Gonapeptyl®Drug: Cerazette®

rFSH / GnRH antagonist cycle

ACTIVE COMPARATOR

Conventional stimulation

Drug: Puregon®Drug: Orgalutran®Drug: Gonapeptyl®

Interventions

Puregon®DRUG

Multiple injections

CFA/PPOS cyclerFSH / GnRH antagonist cycle
Orgalutran®DRUG

Multiple injections

rFSH / GnRH antagonist cycle
Gonapeptyl®DRUG

Double injection

CFA/PPOS cyclerFSH / GnRH antagonist cycle
Cerazette®DRUG

Oral tablet

CFA/PPOS cycle
Elonva®DRUG

Single injection

CFA/PPOS cycle

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

follitropin betaganirelixDesogestrel

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Dominic Stoop, Prof. dr.

CONTACT

093321699Dominic.Stoop@uzgent.be

Kathleen Wijnant, Msc

CONTACT

+32(0)93323013Kathleen.Wijnant@uzgent.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 19, 2023

Study Start

January 27, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)