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
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.
Exclusion Criteria:
Patients who have any medical disorders ( eg. D.M. HTN .Epilepsy ....)
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.
Drug: Thyroxine
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.
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
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Aljazeera Hospital