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

Primary Purpose

Thyroiditis, Autoimmune, Infertility

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Prednisone and Aspirin

Placebo

About this trial

This is an interventional treatment trial for Thyroiditis, Autoimmune

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

prednisone and aspirin

placebo

Arm Description

Outcomes

Primary Outcome Measures

clinical pregnancy rate

ultrasound visualization of the gestational sac

Secondary Outcome Measures

Full Information

NCT ID

NCT05578456

First Posted

October 11, 2022

Last Updated

October 11, 2022

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05578456

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2022 (Anticipated)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroiditis, Autoimmune, Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

prednisone and aspirin

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Prednisone and Aspirin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo 2 starch tablets per day per os

Primary Outcome Measure Information:

Title

clinical pregnancy rate

Description

ultrasound visualization of the gestational sac

Time Frame

3-5 weeks after embryo transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Min Jin, Doctor

Phone

+86-15925602121

min_jin@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min Jin, Doctor

Organizational Affiliation

Zhejiang University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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