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CompletedNCT03289403Updated Dec 27, 2024

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

A Phase 2 interventional study of Immunomodulatory and Thyroxine in Infertility and Autoimmune Thyroiditis, sponsored by Aljazeera Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Aljazeera Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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 ....)

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
194 participants (actual)

Study arms

  • 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

  • Active comparator
    Control group

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

    Drug: Thyroxine

Interventions

  • DrugImmunomodulatory

    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.

  • DrugThyroxine

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

05

What researchers measure

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

06

Study locations

1 site
  • Aljazeera (Al Gazeera) hospital
    Giza, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03289403
Lead sponsor
Aljazeera Hospital
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Mar 7, 2018
Primary completion
Sep 15, 2023
Completion
Jan 20, 2024
Last update
Dec 27, 2024

Study contacts

Ahmed M Sayed, Prof.
study chair · Aljazeera (Al Gazeera) hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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