Current partner codePEPTIDESDE
NCT06175832·Phase 4·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 4

Enrollment

60

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Elonva®

Single injection

DRUG

Puregon®

Multiple injections

DRUG

Orgalutran®

Multiple injections

DRUG

Gonapeptyl®

Double injection

DRUG

Cerazette®

Oral tablet

Timeline

From registration to results.

  1. First posted

    Dec 19, 2023

  2. Study start

    Jan 27, 2025

  3. Primary completion

    Dec 31, 2027

  4. Study completion

    Dec 31, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Dec 26, 2025

Outcomes

What the study measures.

Primary outcomes

Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles

Time frame · 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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

1 registered sites.

Belgium. Showing up to 24 locations stored in the fast local snapshot.

University Hospital Ghent

Ghent, Belgium

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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