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NCT04943146 Clinical Trial

An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity

Thyroid Diseases Clinical Trial

Official title:
An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity Undergoing In Vitro Fertilization

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04943146
Other study ID # 2021-0062
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date March 2022

Study information
Verified date March 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Min Jin
Phone 13588803459
Email jin_min@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thyroid autoimmunity(TAI) per se have adverse effect on pregnancy outcomes，and aspirin and prednisone were used frequently in antithyroid antibodies(ATA) positive infertile women in clinical practice, but the impact of these medicines is still controversial. Therefore, aim of the study was to investigate whether or not the treatment of prednisone in addition to aspirin was capable of improving reproductive outcomes in euthyroid infertile women.

Description:

A multicenter retrospective study performed during the period of 2017 to 2020 and euthyroid infertile women positive for anti-thyroperoxidase antibody (TPOAb) and/or thyroglobulin antibody (TgAb) alone with thyroid stimulating hormone 0.35-4.0mIU/L undergoing first in vitro fertilization and embryo transfer(IVF-ET) cycle were recruited in our study.Data analysis was performed using the Statistics Package for Social Sciences.In the end, the value of prednisone plus aspirin treatment was investigated to make a big contribution on clinical practice.

Recruitment information / eligibility
Status Recruiting
Enrollment 402
Est. completion date March 2022
Est. primary completion date June 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. Both TPOAb and TgAb in all the subjects were measured before ART procedure 2. Thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L 3. Women underwent first embryo transfer without previous IVF history. Exclusion Criteria: 1. Abnormal thyroid function test 2. Women with known autoimmune diseases or clinical presentations of autoimmune disorders

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Prednisone 10 MG+aspirin 100MG
Discontinue medication based on early pregnancy outcome

Locations
Country Name City State
China People's Hospital of Jinhua Jinhua Zhejiang
China Ningbo Women and Children's Hospital Ningbo Zhejiang

Sponsors (3)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Ningbo Women and Children's Hospital, People's Hospital of Jinhua

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate Clinical pregnancy was defined as the existence of a viable embryo within an intrauterine gestational sac 3 mouths
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