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

NCT ID: NCT03289403

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2024-01-20

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Autoimmune Thyroiditis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

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

Group Type EXPERIMENTAL

Immunomodulatory

Intervention Type DRUG

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.

Control group

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

Group Type ACTIVE_COMPARATOR

Thyroxine

Intervention Type DRUG

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

Patients will not receive immunomodulatory drugs

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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 ….)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed M Sayed, Prof.

Role: STUDY_CHAIR

Aljazeera (Al Gazeera) hospital

Locations

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Aljazeera (Al Gazeera) hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ICSI/ Autoimmune thyroiditis

Identifier Type: -

Identifier Source: org_study_id