Back to resultsEffect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer
Primary Purpose
Ovarian Insufficiency, Radiation Exposure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
radioactive iodine
Sponsored by
About this trial
This is an interventional diagnostic trial for Ovarian Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Female patient in childbearing period.
- Female patient with differentiated thyroid carcinoma.
- Underwent thyroidectomy.
- Candidate for radioactive iodine therapy.
Exclusion Criteria:
• Male patients.
- Postmenopausal female patients.
- Female patients with undifferentiated thyroid carcinoma.
- Pregnant female patients.
- Lactating female patients.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention
Arm Description
Outcomes
Primary Outcome Measures
Level of anti-Müllerian (AMH) hormone
Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04396158
Brief Title
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer
Official Title
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Anticipated)
Primary Completion Date
June 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Insufficiency, Radiation Exposure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
self controlled case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
radioactive iodine
Intervention Description
80-200 mCi of radioactive iodine will be given to thyroid cancer patients
Primary Outcome Measure Information:
Title
Level of anti-Müllerian (AMH) hormone
Description
Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patient in childbearing period.
Female patient with differentiated thyroid carcinoma.
Underwent thyroidectomy.
Candidate for radioactive iodine therapy.
Exclusion Criteria:
• Male patients.
Postmenopausal female patients.
Female patients with undifferentiated thyroid carcinoma.
Pregnant female patients.
Lactating female patients.
12. IPD Sharing Statement
Learn more about this trial
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer
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