Thyroid AntiBodies and LEvoThyroxine Study

Phase 1

• Conditions: Thyroid autoimmunity and history of miscarriage or infertility.

• Registration Number: EUCTR2011-000719-19-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-15
• Study Completion: 2019-01-14
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 952

Inclusion Criteria

1. Women trying to conceive 2. History of one or more miscarriage(s)or primary/secondary infertility 3. Age 16 - 40 years at randomisation. 4. Biochemically euthyroid (Free T4 and TSH within specified reference ranges) 5. Thyroid Peroxidase Antibody (TPO) positive 6. Willing and able to give written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Current or past treatment for thyroid disease. 2. Contraindication to levothyroxine treatment. -Thyrotoxicosis. Hypersensitivity to any components tablets. 3. Women taking amiodarone or lithium therapy. 3. Participants in any other blinded, placebo controlled trials on Investigational Medicinal Products in pregnancy. 4. Participants with previous or current cardiac disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified