Effect of Radioiodine Therapy on Ovarian Reserve in Femal... | NCT04396158

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

NCT04396158

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

May 27, 2020Actual

Enrollment

38Estimated

Phase

Not Applicable

Conditions

Ovarian Insufficiency
Radiation Exposure

Interventions

radioactive iodine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2020Estimated

Primary Completion Date

Jun 15, 2021Estimated

Completion Date

Dec 15, 2021Estimated

First Submitted Date

May 16, 2020

First Submission Date that Met QC Criteria

May 16, 2020

First Posted Date

May 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2020

Last Update Posted Date

May 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental		Radiation: radioactive iodine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radioactive iodine	Radiation	80-200 mCi of radioactive iodine will be given to thyroid cancer patients	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of anti-Müllerian (AMH) hormone	Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided