Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy

Completed

• Conditions: Thyroid Diseases; Ovarian Failure
• Interventions: Other: Non Applicable

• Registration Number: NCT06394466
• Lead Sponsor: Rio de Janeiro State University

Brief Summary

The assessment of ovarian reserve is well established based on the dosage of anti-Mullerian hormone (AMH). The clinical applicability of detecting thyroid autoantibodies levels has been discussed as a potential marker of low-grade inflammation. There are no studies about the detection of these autoantibodies in infertile women. Our objective is to evaluate the association between ovarian reserve and thyroid function and its autoimmunity in infertile women seeking for assisted reproductive treatment (ART).Evaluation ot thyroid function in the first trimester in also be evaluated in women submitted to ART.

Detailed Description

The assessment of ovarian reserve is well established based on the dosage of anti-Mullerian hormone (AMH). The clinical applicability of detecting thyroid autoantibodies levels has been discussed as a potential marker of low-grade inflammation. There are no studies about the detection of these autoantibodies in infertile women. Evaluation of TSH profile during ovarian stimulation in ART is also debated in literature with conflicting results. Our objective is to evaluate the association between ovarian reserve and thyroid function and its autoimmunity in infertile women seeking for assisted reproductive treatment (ART) and TSH profile during ovarian stimulation and during the first trimester.

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-27
• Last Update Submitted: 2024-04-27
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 453

Inclusion Criteria

• Inclusion criteria were: women attended in the outpatient clinic with baseline exams before ART and during ovarian stimulation between July 2021 and July 2023

Exclusion Criteria

• Exclusion criteria were: patients with known clinical hypothyroidism, patients using medications that may influence the hypothalamic-pituitary-thyroid axis, such as glucocorticoids in supraphysiological doses; or that could interfere with thyroid hormone metabolism (lithium, amiodarone and aspirin in anti-inflammatory dosages).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing ovarian stimulation in our ART clinic	Non Applicable	Inclusion criteria were: women attended in the outpatient clinic with baseline exams before ART and during ovarian stimulation between July 2021 and July 2023. Exclusion criteria were: patients with known clinical hypothyroidism, patients using medications that may influence the hypothalamic-pituitary-thyroid axis, such as glucocorticoids in supraphysiological doses; or that could interfere with thyroid hormone metabolism (lithium, amiodarone and aspirin in anti-inflammatory dosages).

Primary Outcome Measures

Name	Time	Method
TSH levels during assisted reproductive therapy and first trimester	90 days	TSH, free and total thyroxine, and ioduria in the first trimester

Secondary Outcome Measures

Name	Time	Method
Association between AMH levels and detectable categories of TPO-Ab or Tg-Ab	30 days	AMH, TPO-Ab and Tg-Ab dosages
Correlation between AMH and TSH	30 days	AMH and TSH dosages

Trial Locations

Locations (1)

Vida Assisted Reproduction clinic - Fertility Center; 🇧🇷 RIo de Janeiro, RJ, Brazil