NCT05409729

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

4 years

First QC Date

June 4, 2022

Last Update Submit

June 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Eligibility Criteria

Age13 Years - 45 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients with thyroid dysfunction who seeking fertility

You may qualify if:

  • All reproductive age groups included women less than 35 and women more than 35

You may not qualify if:

  • Previous ovarian surgery Women with long term thyroid hormone replacement Endometriosis History of radiotheraby

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Medical School

Asyut, 71511, Egypt

RECRUITING

Related Publications (2)

  • 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 20.

  • Korevaar TIM, Minguez-Alarcon 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: 10.1089/thy.2017.0582. Epub 2018 Aug 14.

Central Study Contacts

Eman Ahmed Abed Eltawaab, MBBCH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2022

First Posted

June 8, 2022

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

August 1, 2023

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations