- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01843140
Assessing Reproductive Outcomes in Young Female Cancer Survivors Through a National Fertility Preservation Registry
October 27, 2024 updated by: Hui-Chun Irene Su, University of California, San Diego
Fertility Information Research Study
The FIRST project is a national fertility preservation registry for young women facing cancer treatments.
The investigators will examine how different cancers and treatments affect the reproductive health of young survivors.
This prospective cohort study seeks to recruit young women close to time of cancer diagnosis and treatment.
Participants will answer a yearly questionnaire on their current health.
A subset of participants will provide dried blood spots to measure reproductive hormones.
The primary goal of the study is to determine the risk of infertility and time to pregnancy in young female cancer survivors.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- UCSD Moores Cancer Center
-
-
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
18 years to 44 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Young women ages 18-44 who have been diagnosed with cancer or exposed to cancer treatment
Description
Inclusion Criteria:
- Diagnosed with cancer or exposure to cancer treatment
- English speaking
- Ability to consent to the study
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Young female cancer survivors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk of infertility
Time Frame: Annually up to 10 years
|
Participants will be assessed for infertility on average each year from age 18 to 51, the age of natural menopause.
|
Annually up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to pregnancy
Time Frame: Annually up to 10 years
|
Annually up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
May 1, 2011
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
July 26, 2012
First Submitted That Met QC Criteria
April 25, 2013
First Posted (Estimated)
April 30, 2013
Study Record Updates
Last Update Posted (Actual)
October 30, 2024
Last Update Submitted That Met QC Criteria
October 27, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FIRST
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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