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

Zhejiang University

Status and phase: Not yet enrolling; Phase 4

Conditions: Infertility; Thyroiditis, Autoimmune

Treatments: Drug: Placebo; Drug: Prednisone and Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT05578456

2022-0513

Details and patient eligibility

About

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.

Enrollment: 540 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

540 participants in 2 patient groups, including a placebo group

prednisone and aspirin

Experimental group

Treatment:

Drug: Prednisone and Aspirin

placebo

Placebo Comparator group

Treatment:

Drug: Placebo