Assessing Reproductive Outcomes in Young Female Cancer Survivors Through a National Fertility Preservation Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01843140
First received: July 26, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition
Cancer
Infertilty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fertility Information Research Study

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Risk of infertility [ Time Frame: Annually up to 10 years ] [ Designated as safety issue: No ]
    Participants will be assessed for infertility on average each year from age 18 to 51, the age of natural menopause.


Secondary Outcome Measures:
  • Time to pregnancy [ Time Frame: Annually up to 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Dried blood spots


Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Young female cancer survivors

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
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

Criteria

Inclusion Criteria:

  • Diagnosed with cancer or exposure to cancer treatment
  • English speaking
  • Ability to consent to the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843140

Contacts
Contact: Samantha C Bailey 858-822-0768 ayastudy.ucsd@gmail.com

Locations
United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Samantha C Bailey    858-822-0768    ayastudy.ucsd@gmail.com   
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Hui-Chun Irene Su, Assistant Professor of Reproductive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01843140     History of Changes
Other Study ID Numbers: FIRST
Study First Received: July 26, 2012
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
cancer
fertility preservation
infertility
pregnancy

ClinicalTrials.gov processed this record on October 19, 2014