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NCT03289403 Clinical Trial

The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis

Infertility Clinical Trial

Official title:
The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03289403
Other study ID # ICSI/ Autoimmune thyroiditis
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 7, 2018
Est. completion date October 20, 2019

Study information
Verified date June 2020
Source Aljazeera Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date October 20, 2019
Est. primary completion date September 15, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 ….)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Immunomodulatory
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.
• Thyroxine
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle. Patients will not receive immunomodulatory drugs

Locations
Country Name City State
Egypt Aljazeera (Al Gazeera) hospital Giza

Sponsors (1)
Lead Sponsor Collaborator
Aljazeera Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Number of Participants Who Achieved clinical Pregnancy 6 weeks after embryo transfer
Secondary The Number of Participants Who Achieved Ongoing Pregnancy 18 weeks after embryo transfer
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