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

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ClinicalTrials.gov Identifier: NCT03289403
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Aljazeera Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Autoimmune Thyroiditis Drug: Immunomodulatory Drug: Thyroxine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins)
 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.
Active Comparator: Control group
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D.
 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


Outcome Measures
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Primary Outcome Measures :
  1. The Number of Participants Who Achieved clinical Pregnancy [ Time Frame: 6 weeks after embryo transfer ]

Secondary Outcome Measures :
  1. The Number of Participants Who Achieved Ongoing Pregnancy [ Time Frame: 18 weeks after embryo transfer ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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 ….)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289403


Contacts
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Contact: Usama M Fouda, Prof. 01095401375 ext +2 umfrfouda@yahoo.com

Locations
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Egypt
Aljazeera (Al Gazeera) hospital Recruiting
Giza, Egypt
Contact: Usama M. Fouda, M.D , PhD    +0201099930213    umfrfouda@yahoo.com   
Sponsors and Collaborators
Aljazeera Hospital
Investigators
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Study Chair: Ahmed M Sayed, Prof. Aljazeera (Al Gazeera) hospital
More Information
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Responsible Party: Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT03289403     History of Changes
Other Study ID Numbers: ICSI/ Autoimmune thyroiditis
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infertility
Thyroiditis
Thyroiditis, Autoimmune
Hashimoto Disease
Genital Diseases, Male
Genital Diseases, Female
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Aspirin
Vitamin D
Ergocalciferols
Vitamins
Selenium
 Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents