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Status unknownNCT04943146Updated Jun 29, 2021

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

An observational study in Thyroid Diseases, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 2 sites in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-29.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
402
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Thyroid Diseases

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Keywords

  • Prednisolone
  • Assisted reproductive technology
  • Aspirin
  • thyroid diseases
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In context

Thyroid Diseases

967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.

This study's planned enrollment of 402 is above the median of 150 across 381 observational studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  1. Abnormal thyroid function test
  2. Women with known autoimmune diseases or clinical presentations of autoimmune disorders
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
402 participants (estimated)
Patient registry
No

Groups and cohorts

  • control group
  • P+A group

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

    Drug: Prednisone 10 MG+aspirin 100MG

Interventions

  • DrugPrednisone 10 MG+aspirin 100MG

    Discontinue medication based on early pregnancy outcome

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What researchers measure

Primary outcomes

  1. clinical pregnancy rate

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

    Time frame: 3 mouths

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Study locations

2 of 2 sites recruiting
  • People's Hospital of Jinhua
    Jinhua, Zhejiang, China
    Recruiting
  • Ningbo Women and Children's Hospital
    Ningbo, Zhejiang, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided — uncertainty

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04943146
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Ningbo Women & Children's Hospital, People's Hospital of Jinhua
Responsible party
Sponsor
First posted
Jun 29, 2021
Start date
Mar 1, 2021
Primary completion
Jun 2021 (estimated)
Completion
Mar 2022 (estimated)
Last update
Jun 29, 2021

Study contacts

Min Jin
Contact
jin_min@zju.edu.cn
13588803459

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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