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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04943146

Collaborator

Ningbo Women & Children's Hospital (Other), People's Hospital of Jinhua (Other)

402

Enrollment

Locations

Anticipated Duration (Months)

201

Patients Per Site

16.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Diseases	Drug: Prednisone 10 MG+aspirin 100MG

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 Design

Study Type:

Observational

Anticipated Enrollment :

402 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
control group
P+A group aspirin: tablet 100mg qd 2-5weeks prednisone: tablet 10mg qd 2-5weeks	Drug: Prednisone 10 MG+aspirin 100MG Discontinue medication based on early pregnancy outcome

Arm

Intervention/Treatment

control group

P+A group

aspirin: tablet 100mg qd 2-5weeks prednisone: tablet 10mg qd 2-5weeks

Drug: Prednisone 10 MG+aspirin 100MG

Discontinue medication based on early pregnancy outcome

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Both TPOAb and TgAb in all the subjects were measured before ART procedure
Thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L
Women underwent first embryo transfer without previous IVF history.

Exclusion Criteria:

Abnormal thyroid function test
Women with known autoimmune diseases or clinical presentations of autoimmune disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	People's Hospital of Jinhua	Jinhua	Zhejiang	China
2	Ningbo Women and Children's Hospital	Ningbo	Zhejiang	China

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
Ningbo Women & Children's Hospital
People's Hospital of Jinhua

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04943146

Other Study ID Numbers:

2021-0062

First Posted:

Jun 29, 2021

Last Update Posted:

Jun 29, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

Prednisolone

Assisted reproductive technology

Aspirin

thyroid diseases

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021