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

NCT03289403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

Interventions

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: 1. Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued 2. Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin. 3. Immunoglobulins will be used in cases not responding to treatment.

DRUG

Thyroxine

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

Sponsors & Collaborators

  • Aljazeera Hospital

    lead OTHER

Principal Investigators

  • Ahmed M Sayed, Prof. · Aljazeera (Al Gazeera) hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2023-09-15
Completion
2024-01-20

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03289403 on ClinicalTrials.gov