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New treatment option for Ovarian Stimulation
Official title PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
ClinicalTrials.gov ID: NCT06175832
What this study is testing
What is Elonva®?
Elonva® is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for ovarian stimulation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Prescreening: Clarification: Pre-screening might be performed to identify women with AFC \> 5 and AMH \> 1.1 ng/ml (Bologna criteria, AFC and AMH...
- Group 1: indication for oocyte cryopreservation
- Group 2: indication for IVF/ICSI and PGT-A for both groups:
- First ovarian stimulation cycle
- Aged ≥ 18 and \< 41 years old at the time of first OPU
You likely can't join 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;
See the full eligibility 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). for:
- Group 1: indication for oocyte cryopreservation
- Group 2: indication for IVF/ICSI and PGT-A for both groups:
- First ovarian stimulation cycle
- Aged ≥ 18 and \< 41 years old at the time of first OPU
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.