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临床试验/NCT06394466
NCT06394466已完成不适用

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

Rio de Janeiro State University1 个研究点 分布在 1 个国家目标入组 453 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
453
试验地点
1
主要终点
TSH levels during assisted reproductive therapy and first trimester

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

TSH levels during assisted reproductive therapy and first trimester

时间窗: 90 days

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

次要结局

  • Association between AMH levels and detectable categories of TPO-Ab or Tg-Ab(30 days)
  • Correlation between AMH and TSH(30 days)

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuri Ian Lima Alves de Oliveira

M.D.

Rio de Janeiro State University

研究点 (1)

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