Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04943146
Other study ID # 2021-0062
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date March 2022

Study information

Verified date March 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Min Jin
Phone 13588803459
Email jin_min@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 402
Est. completion date March 2022
Est. primary completion date June 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Prednisone 10 MG+aspirin 100MG
Discontinue medication based on early pregnancy outcome

Locations

Country Name City State
China People's Hospital of Jinhua Jinhua Zhejiang
China Ningbo Women and Children's Hospital Ningbo Zhejiang

Sponsors (3)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Ningbo Women and Children's Hospital, People's Hospital of Jinhua

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate Clinical pregnancy was defined as the existence of a viable embryo within an intrauterine gestational sac 3 mouths
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05975866 - The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato N/A
Terminated NCT04589884 - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Completed NCT00569920 - Nausea and Pain Prophylaxis During Thyroid Surgery N/A
Recruiting NCT05917067 - Fluorescence Imaging of the Parathyroid Glands of Children
Completed NCT04704349 - Latest Imaging SPECT System Evaluation Phase 1 N/A
Recruiting NCT05430139 - Dried Blood Spot Testing for At Home Health
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Recruiting NCT05678374 - Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease
Not yet recruiting NCT04094493 - Vit D Role in Post Thyroidectomy Hypocalcemia Early Phase 1
Completed NCT03157466 - Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome
Completed NCT04542278 - Preoperative Steroids in Autoimmune Thyroid Disease Phase 4
Completed NCT04425512 - Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Thyroid Malignancy N/A
Recruiting NCT05510609 - Three-dimensional Ultrasonography Thyroid Volume Measurement. N/A
Recruiting NCT05412680 - Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) N/A
Completed NCT06227819 - BVA-200 vs BVA-100 Validation Study
Completed NCT00150033 - Health-Related Quality of Life for Thyroid Patients Phase 2
Active, not recruiting NCT04351945 - Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Enrolling by invitation NCT04411290 - Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases