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临床试验/NCT05782725
NCT05782725已完成不适用

Subclinical Hypothyroidism and Ovarian Reserve Indices in Women With Normogonadotropic Anovulation

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年3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
300
试验地点
1
主要终点
Blood serum AMH concentration

研究概览

简要总结

Thyroid hormones (TH) can modify the functioning of the hypothalamic-pituitary-ovarian axis, affecting the functions of granulosa cells and the development and apoptosis of preantral follicles. TH receptors are present within the oocytes, and TH and anti-thyroid antibodies (ATA) are present in the follicular fluid. Improper thyroid function can cause ovulation disorders, luteal phase failure, impaired endometrial receptivity and result in implantation failures and recurrent miscarriages. While overt hypothyroidism is treated to improve fertility, the effect of subclinical hypothyroidism (SCH) and the presence of circulating ATAs on fertility and obstetric outcomes is uncertain and data on ovarian reserve rates are conflicting. Among the causes of ovulation disorders (group II according to the WHO classification), polycystic ovary syndrome (PCOS) dominates, found in 3-15% of women of reproductive age, and the remaining group of causes is the so-called Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). The exact etiology of both entities is unknown.

详细描述

Purpose of the study

Evaluation of ovarian reserve indices in women with normogonadotropic anovulation with SCH and without thyroid disease.

Detailed objectives

i) Assessment of AMH, FSH, LH, estradiol, astral follicle count (AFC)/ovarian volume in the subpopulation of women with PCOS and SCH compared to women with PCOS without thyroid disease ii) Assessment of AMH, FSH, LH, estradiol, AFC/ovarian volume in the subpopulation of women with HPOD (other than PCOS) with SCH compared to women with HPOD without thyroid disease iii) Comparison of AMH, FSH, LH, estradiol, AFC/ovarian volume in women with PCOS and HPOD with and without thyroid disease and evaluation of correlation with US ovarian morphology iv) Calculation of the cut-off point of AMH concentration correlating with a high probability of PCOS diagnosis and TSH correlating with unfavorable parameters of ovarian function/HPO axis.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age 18-45
  • irregular periods
  • infertility due to ovulation disorders
  • euthyreosis

排除标准

  • diagnosed and treated thyroid dysfunction,
  • history of thyroidectomy

结局指标

主要结局

Blood serum AMH concentration

时间窗: 01.07.2022-01.12.2023

Measurement of serum AMH concentration in women in 4 arms of the study

次要结局

  • Blood serum FSH, LH, estradiol(01.07.2022-01.12.2023)
  • AFC/ovarian volume(01.07.2022-01.12.2023)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iwona Magdalena Gawron

Principal Investigator

Jagiellonian University

研究点 (1)

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