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NCT05578456 Clinical Trial

Effect of Prednisone and Aspirin on IVF-ET Outcome Among Patients With Thyroid Autoimmunity

Infertility Clinical Trial

Official title:
Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05578456
Other study ID # 2022-0513
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2022
Est. completion date December 31, 2026

Study information
Verified date October 2022
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Min Jin, Doctor
Phone +86-15925602121
Email min_jin@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial was a 1:1 (active:placebo) randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of prednisone and aspirin for the in vitro fertilization and embryo transfer outcome among patients with thyroid autoimmunity.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 540
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 38 Years
Eligibility Inclusion Criteria: 1. TPOAb>34IU/ml and/or TgAb>115IU/ml 2. =5 follicles with average diameter lager than 14 mm at trigger day 3. =5 oocytes retrieved 4. for frozen embryo transfer, at least 2 cleavage stage embryos, among which at least one morphologically good quality embryo, or at least 1 morphologically good quality embryo in blastocyst stage 5. age: 20-38 years old 6. Patients whose written ICF approved by the EC has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved. meet item 1, 5, 6, and one of item 2, 3, 4. Exclusion Criteria: - hyperthyroidism - intrauterine adhesion - with endometrium thickness less than 6mm - uterine malformation - PGT - with other autoimmune diseases need glucocorticoid or aspirin treatment - gluacoma - gastric ulcer

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Prednisone and Aspirin
prednisone 10 mg and aspirin 75-100mg per day per os
• Placebo
placebo 2 starch tablets per day per os

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Jiaxing Maternity and Child Health Care Hospital, Jinhua People's Hospital, Ningbo Women & Children's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate ultrasound visualization of the gestational sac 3-5 weeks after embryo transfer
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