Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy

April 27, 2024 updated by: Yuri Ian Lima Alves de Oliveira, Rio de Janeiro State University

Evaluation of Thyroid Function and Autoimmunity in Subfertility Women and Thyroid Hormone Levels in the First Trimester of Assisted Reproduction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

453

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • RIo de Janeiro, RJ, Brazil, 22631-000
        • Vida Assisted Reproduction clinic - Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women who looked for assisted reproduction and went through the process of ovarian stimulation and oocyte retrieval. The study was carried out with data from the first initial clinic appointment at Vida Assisted Reproduction clinic - Fertility Center (Rio de Janeiro, Brazil). Data collected from the patients in the initial clinical history were: chronological age, cause(s) of infertility, comorbidities and use of medications.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women undergoing ovarian stimulation in our ART clinic
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).
Other: Non Applicable
Non Applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TSH levels during assisted reproductive therapy and first trimester
Time Frame: 90 days
TSH, free and total thyroxine, and ioduria in the first trimester
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between AMH levels and detectable categories of TPO-Ab or Tg-Ab
Time Frame: 30 days
AMH, TPO-Ab and Tg-Ab dosages
30 days
Correlation between AMH and TSH
Time Frame: 30 days
AMH and TSH dosages
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Investigators

  • Principal Investigator: Ana BW Tavares, pHD, Rio de Janeiro State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

April 27, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y201420y

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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