Ovarian InsufficiencyNCT04396158
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer
A study testing radioactive iodine in people with Ovarian Insufficiency and Radiation Exposure, run by Assiut University.
Trial summary
Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Ovarian Insufficiency, Radiation Exposure
- What is being tested?
- radioactive iodine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2020to 15 Dec 2021
- Phase
- Interventional
- 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female patient in childbearing period.
- Female patient with differentiated thyroid carcinoma.
- Underwent thyroidectomy.
- Candidate for radioactive iodine therapy.
Who cannot join
- • Male patients.
- Postmenopausal female patients.
- Female patients with undifferentiated thyroid carcinoma.
- Pregnant female patients.
- Lactating female patients.
About this study
Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. For women with DTC, the effects of RAI therapy on gonadal and reproductive function are an important consideration. This study aimed to evaluate the effects of RAI therapy on ovarian function.
- Conditions
- Ovarian Insufficiency, Radiation Exposure
- Being tested
- radioactive iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioactive iodineRadiation
80-200 mCi of radioactive iodine will be given to thyroid cancer patients
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Radiation: radioactive iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anti-Müllerian (AMH) hormone
Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start15 Jun 2020 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- self controlled case series
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebat Allah Ahmed Askar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396158
- Sponsor's protocol ID
- ovarian reserve
- Status last verified
- May 2020
- First submitted
- 16 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT04396158
- Acronym / sponsor ID
- ovarian reserve
- Conditions
- Ovarian Insufficiency, Radiation Exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 20 May 2020 (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.
Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. For women with DTC, the effects of RAI therapy on gonadal and reproductive function are an important consideration. This study aimed to evaluate the effects of RAI therapy on ovarian function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- self controlled case series
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Radiation: radioactive iodine |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female patient in childbearing period.
- Female patient with differentiated thyroid carcinoma.
- Underwent thyroidectomy.
- Candidate for radioactive iodine therapy.
Key exclusion criteria (5 listed)
- • Male patients.
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 |
|---|---|---|
| radioactive iodine80-200 mCi of radioactive iodine will be given to thyroid cancer patients | Radiation | intervention |
Primary outcome
Level of anti-Müllerian (AMH) hormone
Time frame: 6 months
Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing radioactive iodine in people with Ovarian Insufficiency and Radiation Exposure, run by Assiut University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Level of anti-Müllerian (AMH) hormone (time frame: 6 months). 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 May 2020.