Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer

May 22, 2020 updated by: Hebat Allah Ahmed Askar, Assiut University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
Radiation: radioactive iodine
80-200 mCi of radioactive iodine will be given to thyroid cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2020

Primary Completion (Anticipated)

June 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

May 16, 2020

First Submitted That Met QC Criteria

May 16, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ovarian reserve

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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