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
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Thyroiditis
• Thyroiditis, Autoimmune

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