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NCT05409729 Clinical Trial

Subclinical Hypothyrodism and Ovarian Reserve

Fertility Disorders Clinical Trial

Official title:
Evaluation of Ovarian Reserve in Women With Subclinical Hypothyrodism in Reproductive Age

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05409729
Other study ID # AMH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date August 1, 2023

Study information
Verified date June 2022
Source Assiut University
Contact Eman Ahmed Abed Eltawaab, MBBCH
Phone 01065933793
Email emanedahmed49@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve Primary outcome: Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)

Description:

Thyroid dysfunction is one of the commonest disorders in women of reproductive age .there is association between subclinical hypothyrodism and infertility and ovarian reserve .It's known that subclinical hypothyrodism can be associated with reduced ovarian reserve in women more than 35 years old .Aclear association between subclinical hypothyrodism and ovarian reserve not established in reproductive age in women less than 35 .This retrospective study investigate serum thyroid hormone /Antithyroid hormone ,ovarian reserve markers (basal FSH,AMH,Antral follicle count on day 2-4/prolactin level .

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date August 1, 2023
Est. primary completion date January 1, 2020
Accepts healthy volunteers
Gender Female
Age group 13 Years to 45 Years
Eligibility Inclusion Criteria: - All reproductive age groups included women less than 35 and women more than 35 Exclusion Criteria: - Previous ovarian surgery Women with long term thyroid hormone replacement Endometriosis History of radiotheraby

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• retrospective charts reviewing

Locations
Country Name City State
Egypt Assiut Medical School Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Korevaar TIM, Mínguez-Alarcón L, Messerlian C, de Poortere RA, Williams PL, Broeren MA, Hauser R, Souter IC. Association of Thyroid Function and Autoimmunity with Ovarian Reserve in Women Seeking Infertility Care. Thyroid. 2018 Oct;28(10):1349-1358. doi: — View Citation

Rao M, Wang H, Zhao S, Liu J, Wen Y, Wu Z, Yang Z, Su C, Su Z, Wang K, Tang L. Subclinical Hypothyroidism Is Associated with Lower Ovarian Reserve in Women Aged 35 Years or Older. Thyroid. 2020 Jan;30(1):95-105. doi: 10.1089/thy.2019.0031. Epub 2019 Dec 2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH) This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve 48 months
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