The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03289403 |
Recruitment Status :
Completed
First Posted : September 21, 2017
Last Update Posted : June 22, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility Autoimmune Thyroiditis | Drug: Immunomodulatory Drug: Thyroxine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | March 7, 2018 |
Actual Primary Completion Date : | September 15, 2019 |
Actual Study Completion Date : | October 20, 2019 |

Arm | Intervention/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:
|
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 |
- The Number of Participants Who Achieved clinical Pregnancy [ Time Frame: 6 weeks after embryo transfer ]
- The Number of Participants Who Achieved Ongoing Pregnancy [ Time Frame: 18 weeks after embryo transfer ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
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 ….)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289403
Egypt | |
Aljazeera (Al Gazeera) hospital | |
Giza, Egypt |
Study Chair: | Ahmed M Sayed, Prof. | Aljazeera (Al Gazeera) hospital |
Responsible Party: | Aljazeera Hospital |
ClinicalTrials.gov Identifier: | NCT03289403 |
Other Study ID Numbers: |
ICSI/ Autoimmune thyroiditis |
First Posted: | September 21, 2017 Key Record Dates |
Last Update Posted: | June 22, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
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 |
Infertility Thyroiditis Thyroiditis, Autoimmune Hashimoto Disease |
Thyroid Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |