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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
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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

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

    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
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    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
    No
    Studies a U.S. FDA-regulated Device Product
    No

    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
    No
    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
    Email
    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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