Back to resultsThe Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis
Primary Purpose
Infertility, Autoimmune Thyroiditis
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Immunomodulatory
Thyroxine
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.
Exclusion Criteria:
- All patients who have other autoimmune diseases especially antiphospholipid syndrome, hepatitis c viral disease.
Patients who have any medical disorders ( eg. D.M. HTN .Epilepsy ….)
Sites / Locations
- Aljazeera (Al Gazeera) hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins)
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D.
Outcomes
Primary Outcome Measures
The Number of Participants Who Achieved clinical Pregnancy
Secondary Outcome Measures
The Number of Participants Who Achieved Ongoing Pregnancy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03289403
Brief Title
The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis
Official Title
The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
October 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the work is to determine whether the use of immunomodulatory drugs could improve the reproductive of outcome of infertile patients who have autoimmune thyroiditis with positive autoimmune antibodies undergoing IVF-ET.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Autoimmune Thyroiditis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D.
Intervention Type
Drug
Intervention Name(s)
Immunomodulatory
Intervention Description
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
Moreover, patients will receive a treatment course of immunomodulatory drugs for 3 -6 months before ICSI cycle:
Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued
Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin.
Immunoglobulins will be used in cases not responding to treatment.
Intervention Type
Drug
Intervention Name(s)
Thyroxine
Intervention Description
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
Patients will not receive immunomodulatory drugs
Primary Outcome Measure Information:
Title
The Number of Participants Who Achieved clinical Pregnancy
Time Frame
6 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
The Number of Participants Who Achieved Ongoing Pregnancy
Time Frame
18 weeks after embryo transfer
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.
Exclusion Criteria:
All patients who have other autoimmune diseases especially antiphospholipid syndrome, hepatitis c viral disease.
Patients who have any medical disorders ( eg. D.M. HTN .Epilepsy ….)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Sayed, Prof.
Organizational Affiliation
Aljazeera (Al Gazeera) hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aljazeera (Al Gazeera) hospital
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis
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