- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02515916
Fertility Preservation- Oncology Treatment Effects and Psychological Impact
Study Overview
Detailed Description
This will be a prospective, non-randomized, uncontrolled study examining the effects of oncology treatments in women at risk for treatment induced ovarian failure. The investigators will also assess and describe the emotional, reproductive and quality of life concerns of newly diagnosed cancer patients referred for fertility preservation and determine the physical, psychosocial and quality of life differences of cancer survivors who undergo fertility preservation in comparison to those who choose not to or are unsuccessful in their attempts to cryopreserve.
Protocol Methodology:
Women who are scheduled to undergo chemotherapy and/or radiation and present for fertility preservation consultation at The Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine will be recruited for this study. All recruited patients (including those who undergo cryopreservation of embryos, eggs or ovarian tissue, those who do not undergo cryopreservation of embryos, eggs or ovarian tissue, and those who are unable to undergo cryopreservation) will be evaluated at the following time points: T1: Before starting chemotherapy initial consultation for fertility preservation; T2: Pre oncology treatment (eg chemotherapy and/or radiation; T3: At six months to 1 year post chemotherapy; Patients will subsequently have annual follow up visit for 3 years. The study involves two components: 1) Assessment of biochemical and biophysical parameters of ovarian reserve. 2) Assessment of psychosocial, reproductive and quality of life concerns of these patients
The investigators will evaluate biochemical and biophysical parameters of ovarian reserve in these patients. Anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), estradiol (E2) levels will be drawn. In addition, the ovaries will be examined and antral follicle counts and ovarian volume will be measured on the same days that the hormone levels are drawn (if appropriate). Subjects will be asked to keep a menstrual calendar diary from baseline (pre-chemotherapy) and for 1 year post chemotherapy.
In order to assess and describe the psychosocial, reproductive and quality of life concerns of these patients, a Quality of Life (QOL) survey will be completed pre and post chemotherapy at time points:
T1: At the time of pre-chemotherapy (initial consultation for fertility preservation).
T2: Pre chemotherapy/radiation treatment. Patients who have successful cryopreservation of embryos or eggs will be asked to complete the survey on the day of embryo or egg cryopreservation or before the start date of their initial chemotherapy treatment. Patients who do not have successful cryopreservation of embryos or eggs will be asked to complete the survey after receiving notification that the fertility preservation treatment is cancelled. Patients who do not choose to cryopreserve embryos or eggs will be asked to fill out the survey before the start date of their initial chemotherapy treatment. Participants will be mailed or given a survey instrument and the data collected either in person, by mail, or by telephone.
T3: At six months to 1 year post chemotherapy, patients will be asked to complete the final survey by phone or by mail. Systematic reminders (mail and phone) will be used to ensure return of the surveys. Each study survey should take approximately 40-55 minutes to complete. The domains assessed will include psychological functioning, reproductive and fertility preservation concerns, relationship satisfaction, and quality of life prior to and following potential fertility preservation and initial chemotherapy treatment for breast cancer. Participants do not have to respond to any question that they choose not to answer.
Study Instruments: Quality of Life (QOL) survey-
- Psychosocial History and Background Information Form
- Symptom Checklist (SCL)
- Center for Epidemiologic Studies-Depression (CES-D)
- Dyadic Adjustment Scale (DAS)
- The Reproductive Concerns Scale (RCS)
- Impact of Events Scale (IES)
- The Life Orientation Test (LOT-R)
- The Functional Assessment of Cancer Therapy-General
Data will be collected and analyzed. This new data will help us establish a better understanding of the effects of chemotherapy on total ovarian reserve and assist clinicians caring for patients of reproductive age in counseling these patients. The findings of study will also bring attention to the understudied area of fertility preservation and cancer survivorship. The investigators propose that by studying the short and long-term psychosocial impact of fertility preservation with comparison between those who undergo cryopreservation with those who do not, the investigators will be able to assess if psychosocial changes occur over time and identify points for future intervention.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women ages 18-45
- Women seeking fertility preservation at WCMC
- Women who will undergo oncology treatments that will likely cause reduced fertility potential.
Exclusion Criteria:
- Women who do not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AMH (anti-mullerian hormone) blood levels
Time Frame: Up to 3 years
|
To determine if fertility reserve is affected by oncology treatment.
|
Up to 3 years
|
Quality of life on the Dyadic Adjustment Scale
Time Frame: 3 years
|
To determine if there is any psychological impact of oncology treatment.
|
3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Glenn Schattman, MD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1301013407
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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