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

NCT03289403 | Completed Phase 2 DMC

• 1 other identifier: ICSI/ Autoimmune thyroiditis
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Autoimmune Thyroiditis

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Achieved clinical Pregnancy

  6 weeks after embryo transfer

Secondary Outcomes (1)

• The Number of Participants Who Achieved Ongoing Pregnancy

  18 weeks after embryo transfer

Study Arms (2)

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)

Drug: Immunomodulatory

Control group

ACTIVE COMPARATOR

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

Drug: Thyroxine

Interventions

Immunomodulatory 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.

Study group

Thyroxine DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.

You may not qualify if:

• 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 ….)

Sponsors & Collaborators

• Aljazeera Hospital: lead

Study Sites (1)

Aljazeera (Al Gazeera) hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Infertility; Thyroiditis, Autoimmune

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ahmed M Sayed, Prof.

  Aljazeera (Al Gazeera) hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: September 21, 2017
• Study Start: March 7, 2018
• Primary Completion: September 15, 2023
• Study Completion: January 20, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)