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

• Conditions: Thyroid Diseases
• Interventions: Drug: Prednisone 10 MG+aspirin 100MG

• Registration Number: NCT04943146
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-01
• Primary Completion: 2021-06
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 402

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
P+A group	Prednisone 10 MG+aspirin 100MG	aspirin: tablet 100mg qd 2-5weeks prednisone: tablet 10mg qd 2-5weeks

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	3 mouths	Clinical pregnancy was defined as the existence of a viable embryo within an intrauterine gestational sac

Trial Locations

Locations (2)

Ningbo Women and Children's Hospital; 🇨🇳 Ningbo, Zhejiang, China

People's Hospital of Jinhua; 🇨🇳 Jinhua, Zhejiang, China