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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289403
• Other study ID #: ICSI/ Autoimmune thyroiditis
• Status: Completed
• Phase: Phase 2
• Start date: March 7, 2018
• Est. completion date: October 20, 2019

Study information

• Verified date: June 2020
• Source: Aljazeera Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 20, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 ….)

Related Conditions & MeSH terms

• Autoimmune Thyroiditis
• Hashimoto Disease
• Infertility
• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

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.
• Thyroxine
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle. Patients will not receive immunomodulatory drugs

Locations

Country	Name	City	State
Egypt	Aljazeera (Al Gazeera) hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Aljazeera Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Who Achieved clinical Pregnancy		6 weeks after embryo transfer
Secondary	The Number of Participants Who Achieved Ongoing Pregnancy		18 weeks after embryo transfer