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

Sponsor
Aljazeera Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03289403
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
19.4
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual 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 :
Mar 7, 2018
Actual Primary Completion Date :
Sep 15, 2019
Actual Study Completion Date :
Oct 20, 2019

Arms and Interventions

ArmIntervention/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: Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin. 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

Primary Outcome Measures

  1. The Number of Participants Who Achieved clinical Pregnancy [6 weeks after embryo transfer]

Secondary Outcome Measures

  1. The Number of Participants Who Achieved Ongoing Pregnancy [18 weeks after embryo transfer]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
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 ….)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Aljazeera (Al Gazeera) hospitalGizaEgypt

Sponsors and Collaborators

  • Aljazeera Hospital

Investigators

  • Study Chair: Ahmed M Sayed, Prof., Aljazeera (Al Gazeera) hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aljazeera Hospital
ClinicalTrials.gov Identifier:
NCT03289403
Other Study ID Numbers:
  • ICSI/ Autoimmune thyroiditis
First Posted:
Sep 21, 2017
Last Update Posted:
Jun 22, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:

Study Results

No Results Posted as of Jun 22, 2020