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临床试验/NCT02710175
NCT02710175Unknown不适用

TSH and AMH in Infertile Women

Ain Shams Maternity Hospital0 个研究点目标入组 2 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2
主要终点
TSH Levels in mIU/L

研究概览

简要总结

Infertility is defined as the inability of a couple to achieve pregnancy over an average period of one year (in women under 35 years of age) or 6 months (in women above 35 years of age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or both. It can be either primary or secondary.

Thyroid dysfunction and autoimmune thyroiditis are known adverse risk factors for pregnancy as well as fertility, regardless of the presence of disease in women of reproductive age. In particular, hypothyroid women are at an increased risk of menstrual disorders and infertility because of altered peripheral estrogen metabolism, hyperprolactinaemia and abnormal release of gonadotropin-releasing hormone.

The prevalence of subclinical hypothyroidism characterized by aberrant high serum thyroid-stimulating hormone (TSH) levels with normal free thyroxin (FT4) levels in infertile women are reported to be approximately 20% and it is a primary cause of subfertility.

Indeed, average TSH levels in infertile women were reportedly higher than those in normal fertile women. And elevated serum TSH levels were associated with diminished ovarian reserve in infertile patients. Moreover, although levothyroxine replacement therapy for subclinical hypothyroidism in infertile patients remains debatable, thyroxin supplementation may improve fertility to successful pregnancy.

This data suggests that hypothyroidism is strongly correlated with infertility (Velkeniers et al., 2013).

On the other hand, female fecundity decreases with increasing age, primarily because of decreased ovarian function. Anti-mullerian hormone (AMH) is a dimeric glycoprotein belonging to the transforming growth factor-beta (TGF-B) super family, which act on tissue growth and differentiation. It is produced by the granulosa cells from pre-antral and small antral follicles. Ovarian research after oophorectomy showed that serum AMH levels were closely correlated with the number of primordial follicles; therefore, AMH is a suitable biomarker of ovarian age in women of reproductive age.

Expectedly, ovarian function may be affected by impaired thyroid function, although this association has not been elucidated. In this study, we will evaluate the relationship between thyroid function and AMH levels by comparing them in infertile patients and healthy fertile women.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 20-35 years
  • Diagnosed as primary infertility.
  • Duration of marriage more than 1 year.
  • Controls should be normal fertile women aged 20- 35 years had no history of treatment for infertility or thyroid disorders.

排除标准

  • Age: above 35 years old.
  • Women with ovarian dysfunction (PCO, post ovarian surgery).
  • Treated thyroid dysfunction (Autoimmune thyroiditis, hypothyroidism).

结局指标

主要结局

TSH Levels in mIU/L

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haitham Hassan Ahmed

Maghagha general hospital

Ain Shams Maternity Hospital

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