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:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT05524259
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age
* Diagnosis of PCOS according to the Rotterdam consensus criteria and confirmed by a gynaecologist
* A viable singleton pregnancy confirmed by ultrasound
* Being able to initiate the use of study supplements between 8+0 and 16+0 weeks gestational age
* Ability to understand Dutch or English
* Ability to provide written informed consent
Exclusion Criteria:
* Diagnosis of pre-existent type-1 or 2 diabetes mellitus
* Pre-existent renal failure, defined as an estimated glomerular filtration rate (eGFR) less than 50 ml/min/1.73m2
* Use of myo-inositol supplements, other insulin-mimetics, hypoglycaemic agents (e.g. metformin) and/or systemic steroids, that cannot be discontinued at the time of inclusion
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05524259
Study Brief:
Protocol Section:
NCT05524259