Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy

NCT06394466 | Completed

• 1 other identifier: Y201420y
• Study Type: observational
• Target: 453
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Failure; Thyroid Diseases

Keywords

Anti mullerian hormone; Thyroid autoimmunity; Antithyroid antibodies; Infertility

Outcome Measures

Primary Outcomes (1)

• TSH levels during assisted reproductive therapy and first trimester

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

  90 days

Secondary Outcomes (2)

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

  30 days

• Correlation between AMH and TSH

  30 days

Study Arms (1)

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

Interventions

Non Applicable OTHER

Non Applicable

Women undergoing ovarian stimulation in our ART clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Rio de Janeiro State University: lead

Study Sites (1)

Vida Assisted Reproduction clinic - Fertility Center

Rio de Janeiro, Rio de Janeiro, 22631-000, Brazil

Location

MeSH Terms

Conditions

Thyroid Diseases; Infertility

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Ana BW Tavares, pHD

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: July 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

BR (1)