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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04943146
Enrollment
402
Registered
2021-06-29
Start date
2021-03-01
Completion date
2022-03-31
Last updated
2021-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Diseases

Keywords

Prednisolone, Assisted reproductive technology, Aspirin, thyroid diseases

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.

Interventions

DRUGPrednisone 10 MG+aspirin 100MG

Discontinue medication based on early pregnancy outcome

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rate3 mouthsClinical pregnancy was defined as the existence of a viable embryo within an intrauterine gestational sac

Countries

China

Contacts

Primary ContactMin Jin
jin_min@zju.edu.cn13588803459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026