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

NCT ID: NCT05578456

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroiditis, Autoimmune Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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prednisone and aspirin

Group Type EXPERIMENTAL

Prednisone and Aspirin

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo 2 starch tablets per day per os

Interventions

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Prednisone and Aspirin

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

Intervention Type DRUG

Placebo

placebo 2 starch tablets per day per os

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ningbo Women & Children's Hospital

OTHER

Sponsor Role collaborator

Jinhua People's Hospital

OTHER

Sponsor Role collaborator

Jiaxing Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Jin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Central Contacts

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Min Jin, Doctor

Role: CONTACT

+86-15925602121

Other Identifiers

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2022-0513

Identifier Type: -

Identifier Source: org_study_id

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