InfertilityPhase 2NCT03289403
The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis
A Phase 2 study testing Immunomodulatory and Thyroxine in people with Infertility and Autoimmune Thyroiditis, run by Aljazeera Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility, Autoimmune Thyroiditis
- What is being tested?
- Immunomodulatory and Thyroxine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2018to 20 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.
Who cannot join
- 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 ….)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility 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.
- Conditions
- Infertility, Autoimmune Thyroiditis
- Being tested
- Immunomodulatory, Thyroxine
- Medical subject headings
- Infertility, Thyroiditis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunomodulatoryDrug
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.
ThyroxineDrug
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
Patients will not receive immunomodulatory drugs
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Immunomodulatory |
| Control group | Active comparator | Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D. Receives: Drug: Thyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Achieved clinical Pregnancy
Measured: 6 weeks after embryo transfer
Secondary outcomes (1)
The Number of Participants Who Achieved Ongoing Pregnancy
Measured: 18 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start7 Mar 2018
- Primary completion15 Sep 2023
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Sayed, Prof., Study chair, Aljazeera (Al Gazeera) hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289403
- Sponsor's protocol ID
- ICSI/ Autoimmune thyroiditis
- Status last verified
- Dec 2024
- First submitted
- 17 Sep 2017
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis
- ClinicalTrials.gov ID
- NCT03289403
- Acronym / sponsor ID
- ICSI/ Autoimmune thyroiditis
- Conditions
- Infertility, Autoimmune Thyroiditis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: ImmunomodulatoryPatients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins) |
| Control group | Active comparator | Drug: ThyroxinePatients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.
Key exclusion criteria (2 listed)
- 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 ….)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunomodulatoryPatients 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. | Drug | Study group |
| ThyroxinePatients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle. Patients will not receive immunomodulatory drugs | Drug | Control group |
Primary outcome
The Number of Participants Who Achieved clinical Pregnancy
Time frame: 6 weeks after embryo transfer
1 secondary outcome
The Number of Participants Who Achieved Ongoing Pregnancy
Time frame: 18 weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Sayed, Prof. study chair
Aljazeera (Al Gazeera) hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunomodulatory and Thyroxine in people with Infertility and Autoimmune Thyroiditis, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Who Achieved clinical Pregnancy (time frame: 6 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.