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

NCT04943146 | Unknown FDA Drug

• 1 other identifier: 2021-0062
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 2

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.

Conditions

Thyroid Diseases

Keywords

Prednisolone; Assisted reproductive technology; Aspirin; thyroid diseases

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  Clinical pregnancy was defined as the existence of a viable embryo within an intrauterine gestational sac

  3 mouths

Study Arms (2)

control group

P+A group

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

Drug: Prednisone 10 MG+aspirin 100MG

Interventions

Prednisone 10 MG+aspirin 100MG DRUG

Discontinue medication based on early pregnancy outcome

P+A group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: we investigate pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

People's Hospital of Jinhua

Jinhua, Zhejiang, China

RECRUITING

Ningbo Women and Children's Hospital

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Prednisone; Aspirin

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Min Jin

CONTACT

13588803459; jin_min@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: March 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: March 1, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-03

Locations

CN (2)