NCT03289403

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Aljazeera Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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

• Infertility
• Autoimmune Thyroiditis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-07
• Primary completion: 2023-09-15
• Completion: 2024-01-20
• First posted: 2017-09-21
• Last updated: 2024-12-27

Locations

1 site across 1 country: Egypt