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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT01465867
Eligibility Criteria:
Inclusion Criteria:
* pregnant women with 10°± 2 weeks of gestation
* women in whom embryo transfer is expected within 60 days
* euthyroid women (0.4 μIU/ml \< TSH \< 2.5 μIU/ml), positive for TPOab and/or TgAb, not assuming LT4 replacement
* euthyroid women (0.4 μIU/ml \< TSH \< 2.5 μIU/ml), positive for TPOab and/or TgAb under LT4 replacement (to maintain TSH within the control range).
* women with TSH \> 2.5 μIU/ml positive for TPOab and/or TgAb, not assuming LT4 replacement (requiring the beginning of LT4 replacement)
* women with TSH \> 2.5 μIU/ml positive for TPOab and/or TgAb, under LT4 replacement (requiring an adjustment of LT4 replacement)
Exclusion Criteria:
* use of dietary supplements containing selenium in the previous 4 months;
* use of antidepressive/psychotic drugs, amiodarone, propanolol, lithium, cytokines;
* history of hyperthyroidism positive anti-thyrotropin ab;
* previous partial or total thyroidectomy;
* known fetal anomaly;
* known infections (PID, HIV, HCV) and mola hydatidoses;
* chronic renal failure;
* uncontrolled hypertension;
* uterine malformation;
* history of medical and metabolic complication such as heart disease or diabetes;
* previous embryo transfer failed within last 3 months;
* miscarriage within last 3 months;
* gestational diabetes in previous pregnancies.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
38 Years
Study:
NCT01465867
Study Brief:
Protocol Section:
NCT01465867