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

Aljazeera Hospital

Status and phase: Completed; Phase 2

Conditions: Infertility; Autoimmune Thyroiditis

Treatments: Drug: Thyroxine; Drug: Immunomodulatory

Study type: Interventional

Funder types: Other

Identifiers

NCT03289403

ICSI/ Autoimmune thyroiditis

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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 ....)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Study group

Experimental group

Description:

Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins)

Treatment:

Drug: Immunomodulatory

Control group

Active Comparator group

Description:

Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D.

Treatment:

Drug: Thyroxine