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
About this trial
This is an interventional treatment trial for Thyroiditis, Autoimmune
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
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
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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