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Clinical Trials/NCT03289403
NCT03289403CompletedPhase 2

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

Aljazeera Hospital1 site in 1 country194 target enrollmentStarted: March 7, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
194
Locations
1
Primary Endpoint
The Number of Participants Who Achieved clinical Pregnancy
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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 ....)

Arms & Interventions

Study group

Experimental

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

Intervention: Immunomodulatory (Drug)

Control group

Active Comparator

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

Intervention: Thyroxine (Drug)

Outcomes

Primary Outcomes

The Number of Participants Who Achieved clinical Pregnancy

Time Frame: 6 weeks after embryo transfer

Secondary Outcomes

  • The Number of Participants Who Achieved Ongoing Pregnancy(18 weeks after embryo transfer)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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