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Completed

NCT Number: NCT06394466

Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy

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.

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Key information

Conditions

Ovarian Failure Endocrine System Diseases Genital Diseases Infertility Thyroid Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Vida Assisted Reproduction clinic - Fertility Center

Rio de Janeiro, 22631-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Non applicable

Other

Non Applicable

Primary outcomes

  1. TSH levels during assisted reproductive therapy and first trimester

    Time frame: 90 days

    TSH, free and total thyroxine, and ioduria in the first trimester

Secondary outcomes

  1. Association between AMH levels and detectable categories of TPO-Ab or Tg-Ab

    Time frame: 30 days

    AMH, TPO-Ab and Tg-Ab dosages

  2. Correlation between AMH and TSH

    Time frame: 30 days

    AMH and TSH dosages

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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