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

NCT05578456 | Not Yet Recruiting Phase 4

• 1 other identifier: 2022-0513
• Study Type: interventional
• Target: 540
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroiditis, Autoimmune; Infertility

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  ultrasound visualization of the gestational sac

  3-5 weeks after embryo transfer

Study Arms (2)

prednisone and aspirin

EXPERIMENTAL

Drug: Prednisone and Aspirin

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Prednisone and Aspirin DRUG

prednisone 10 mg and aspirin 75-100mg per day per os

prednisone and aspirin

Placebo DRUG

placebo 2 starch tablets per day per os

placebo

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• TPOAb\>34IU/ml and/or TgAb\>115IU/ml
• ≥5 follicles with average diameter lager than 14 mm at trigger day
• ≥5 oocytes retrieved
• 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
• age: 20-38 years old
• 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.

You may not qualify if:

• hyperthyroidism
• intrauterine adhesion
• with endometrium thickness less than 6mm
• uterine malformation
• PGT
• with other autoimmune diseases need glucocorticoid or aspirin treatment
• gluacoma
• gastric ulcer

Sponsors & Collaborators

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

MeSH Terms

Conditions

Thyroiditis, Autoimmune; Infertility

Interventions

Prednisone; Aspirin

Condition Hierarchy (Ancestors)

Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Min Jin, Doctor

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Jin, Doctor

CONTACT

+86-15925602121; min_jin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 13, 2022

Record last verified: 2022-10