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

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.

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Key information

Conditions

Thyroiditis, Autoimmune Autoimmune Diseases Endocrine System Diseases Genital Diseases Immune System Diseases Infertility Thyroid Diseases Thyroiditis Urogenital Diseases

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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

Treatment and study plan

Prednisone and Aspirin

Drug

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

Placebo

Drug

placebo 2 starch tablets per day per os

Primary outcomes

clinical pregnancy rate

Time frame: 3-5 weeks after embryo transfer

ultrasound visualization of the gestational sac

Study contacts

Contact information is provided by the study sponsor or research team.

Min Jin, Doctor

CONTACT

[email protected]

+86-15925602121

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

Jiaxing Maternity and Child Health Care Hospital
Jinhua People's Hospital
Ningbo Women & Children's Hospital

Registry information

Official study title

Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Oct 13, 2022
Registry last updated: Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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