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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT05746793
Eligibility Criteria:
Inclusion Criteria:
* First time oocyte acceptors Or Nulliparous PCOS patients undergoing ART (IVF/ICSI)
* Criteria for PCOS: two out of the three following criteria must be present:
1. Oligo-or anovulation: a menstrual cycle \>35 days
2. Hyperandrogenism:
* Clinically: the presence of hirsutism and/ or severe acne in combination with alopecia confirmed hyperandrogenism Or
* Biochemically: serum total testosterone \>52 ng/dl or calculated free testosterone \>0,64 ng/dl
3. Polycystic ovaries:
* Follicle number per ovary (FNPO) ≥ 12 on both ovaries Or
* Ovarian volume ≥ 10 ml in both ovaries Or
* One ovary with ≥ 20 follicles (Using endovaginal US transducers with a frequency bandwidth that includes 8 MHz) Or
* AMH ≥ 4,9 ng/ml
Exclusion Criteria:
* Known essential hypertension or development of a new-onset hypertension before 20 weeks' gestation
* Hypertension is defined as a systolic blood pressure ≥ 140 or a diastolic blood pressure ≥ 90 on two separate measurements with at least 20 minutes in between, taken when the patients is in a seated position Or
* The patient is known with hypertension, diagnosed by a certified doctor
* Known diabetes type 1 or 2 before pregnancy
* Diagnosis of diabetes is confirmed when one of the following is present:
* Fasting glucose ≥ 126 mg/dl
* A 2-hour plasma glucose level ≥ 200 mg/dL during a 75-g oral glucose tolerance test Or
* The patient is known with diabetes (type 1 or 2), diagnosed by a certified doctor
* Thyroid dysfunction not under control with medication:
* Hyperthyroidism, the diagnoses is made when:
* Peripheral blood TSH \<0,5 mIU/L and fT4 \>1,9 ng/dl Or
* When the patient is known with hyperthyroidism diagnosed by a certified physician
* Hypothyroidism, the diagnosis is made when:
* Peripheral blood TSH \>5 mIU/L and fT4 \<0,7 ng/dl Or
* When the patient is known with hypothyroidism diagnosed by a certified physician
* Other endocrinological disorder (including Cushing syndrome, Adrenal insufficiency, acromegaly): for diagnosis we will trust the opinion of the certified endocrinologist
* Cardiovascular diseases (including coronary artery disease, arrhythmia, heart valve disease and heart failure): for diagnosis we will trust the opinion of the certified cardiologist
* Renal disease/insufficiency: for diagnosis we will trust the opinion of the certified nephrologist
* Systemic lupus erythematosus: for diagnosis we will trust the opinion of the certified internal medicine doctor
* Antiphospholipid syndrome: for diagnosis we will trust the opinion of the certified internal medicine doctor
* Liver dysfunction/disease: for diagnosis we will trust the opinion of the certified gastroenterologist
* History of prior pre-eclampsia
* Women pregnant with a fetus with known abnormalities such chromosomal anomalies, structural deformities of limbs or organs or any other prebirth diagnosed syndromes or defects
* Multiple pregnancy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT05746793
Study Brief:
Protocol Section:
NCT05746793