Clinical trial NCT06394466: Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy
Official title: Evaluation of Thyroid Function and Autoimmunity in Subfertility Women and Thyroid Hormone Levels in the First Trimester of Assisted Reproduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Failure
Thyroid Diseases
Keywords: Anti mullerian hormone
Thyroid autoimmunity
Antithyroid antibodies
Infertility
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 453
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: TSH levels during assisted reproductive therapy and first trimester
timeFrame: 90 days
Secondary outcomes:
measure: Association between AMH levels and detectable categories of TPO-Ab or Tg-Ab
timeFrame: 30 days
measure: Correlation between AMH and TSH
timeFrame: 30 days
Other outcomes:
Locations:
city: RIo de Janeiro
country: Brazil
facility: Vida Assisted Reproduction clinic - Fertility Center
state: RJ
Study officials:
affiliation: Rio de Janeiro State University
name: Ana BW Tavares, pHD
role: PRINCIPAL_INVESTIGATOR
References: