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OpenTrials
Completed

NCT Number: NCT03289403

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

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.

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Key information

Conditions

Infertility Autoimmune Diseases Autoimmune Thyroiditis Endocrine System Diseases Genital Diseases Immune System Diseases Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Aljazeera (Al Gazeera) hospital

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ….)

Treatment and study plan

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:

  • 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

Drug

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

Patients will not receive immunomodulatory drugs

Primary outcomes

  1. The Number of Participants Who Achieved clinical Pregnancy

    Time frame: 6 weeks after embryo transfer

Secondary outcomes

  1. The Number of Participants Who Achieved Ongoing Pregnancy

    Time frame: 18 weeks after embryo transfer

Sponsors and collaborators

Lead sponsor

Aljazeera Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Sep 21, 2017
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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