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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01046032
Eligibility Criteria:
Inclusion Criteria:
* Women attending with ovulatory PCO due to undergo IVF/ICSI treatment.
* First or second cycle of IVF/ICSI.
* If previously on metformin, a minimum one month washout period was required.
* Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm in diameter in at least one ovary and/or increased ovarian volume (≥10 ml).
* Written informed consent.
Exclusion Criteria:
* Clinical manifestations of PCOS, including any of the following:
1. Oligo- or amenorrhoea with cycles ≥42 days apart.
2. Anovulation with mid-luteal progesterone \<16 nmol/L.
3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index \>5 (FAI = \[total testosterone/SHBG\] x 100).
4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly.
* Age \>38 years.
* BMI \>35 kg/m2.
* Basal FSH \>12 IU/L.
* Liver disease or ALT \>80 IU/L.
* Renal disease, or creatinine \>130 nmol/L.
* Alcoholism or drug abuse.
* Diabetes mellitus (evaluated by fasting glucose \>6.7mmol/L).
* Per oral steroid treatment in last month.
* Cimetidine, anticoagulation, erythromycin, or other macrolides in last month.
* Hyperprolactinemia (Prolactin \>700 mIU/L).
* Abnormal thyroid function tests (TSH outside of laboratory normal range).
* Congenital adrenal hyperplasia.
Healthy Volunteers:
True
Sex:
FEMALE
Maximum Age:
38 Years
Study:
NCT01046032
Study Brief:
Protocol Section:
NCT01046032