Clincosm LogoSign in Get a demo

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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05578456
Collaborator
Ningbo Women & Children's Hospital (Other), Jinhua People's Hospital (Other), Jiaxing Maternity and Child Health Care Hospital (Other)
540
Enrollment
2
Arms
50
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Prednisone and Aspirin
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
540 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: prednisone and aspirin

Drug: Prednisone and Aspirin
prednisone 10 mg and aspirin 75-100mg per day per os
Placebo Comparator: placebo

Drug: Placebo
placebo 2 starch tablets per day per os

Outcome Measures

Primary Outcome Measures

  1. clinical pregnancy rate [3-5 weeks after embryo transfer]

    ultrasound visualization of the gestational sac

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 38 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Ningbo Women & Children's Hospital
  • Jinhua People's Hospital
  • Jiaxing Maternity and Child Health Care Hospital

Investigators

  • Principal Investigator: Min Jin, Doctor, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05578456
Other Study ID Numbers:
  • 2022-0513
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Thyroiditis
Thyroiditis, Autoimmune
Aspirin
Prednisone

Study Results

No Results Posted as of Oct 13, 2022