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

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Jiaxing Maternity and Child Health Care Hospital; Jinhua People's Hospital; Ningbo Women & Children's Hospital
• Treatments: Aspirin; Prednisone

Criteria

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