Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT07274202
Eligibility Criteria:
Inclusion Criteria:
* Age from \>18 to \<35 years
* Patients with a PCOS diagnosis: The PCOS diagnosis will be based on the ESHRE PCOS guideline (2023) and the evidence-based methodology workshop on polycystic ovary syn-drome, December 3-5, 2012 using the following classification: Phenotype A (hyperandro-genism + oligo-/amenorrhea + PCOM), Phenotype C (hyperandrogenism + PCOM) and Phenotype D (oligo-/amenorrhea + PCOM). Hyperandrogenism is defined as the presence of clinical and/or biochemical hyperandrogenism following the ESHRE PCOS guideline, 2023. Oligomenorrhea or amenorrhea is considered as an average cycle duration \> 35 days.
* A serum AMH concentration of \>10.00 ng/ml as measured using the Elecsys platform by Roche at UZ Brussel. Threshold of 10 ng/mL or higher was adopted based on the result of a multivariable analysis by our group (Mostinckx et al. (2024)), which showed that ongoing pregnancy rates in women with AMH of 10ng/mL or higher did not depend on the type of treatment (IVM vs. cOS).
* Embarking on their first round of ART treatment at Brussels IVF.
* Eligible for ART either because previous treatment with ovulation induction failed and/or because of male factor infertility.
* Patients must be able to speak Dutch, French or English.
Exclusion Criteria:
* BMI \<18 or \>35 kg/m²
* Patients with a general anesthesia during oocyte retrieval
* Patients with a PCOS phenotype B will be excluded from the trial since these patients do not polycystic ovaries on ultrasound scan and are therefore not considered hyperrespond-ers.
* Patients who do not have a partner
* Need for preimplantation genetic testing (PGT)
* high grade endometriosis (\> grade 2)
* Couples who need donor oocytes
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT07274202
Study Brief:
Protocol Section:
NCT07274202