Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02710175
Status:
UNKNOWN
Last Update Posted:
2016-03-16
First Post:
2015-12-30
Brief Title:
TSH And AMH in Infertile Women
Sponsor:
Ain Shams Maternity Hospital
Organization:
Ain Shams Maternity Hospital
Study Overview
Official Title:
TSH and AMH in Infertile Women
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None