Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02515916 |
| Other study ID # |
1301013407 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2017 |
| Est. completion date |
March 12, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Weill Medical College of Cornell University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is assess the effects of oncology treatment on ovarian reserve and
also to better understand the experiences, thoughts and feelings of women scheduled to
undergo chemotherapy/radiotherapy and seeking fertility preservation at Weill Cornell Medical
College (WCMC).
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-
1. Psychosocial History and Background Information Form
2. Symptom Checklist (SCL)
3. Center for Epidemiologic Studies-Depression (CES-D)
4. Dyadic Adjustment Scale (DAS)
5. The Reproductive Concerns Scale (RCS)
6. Impact of Events Scale (IES)
7. The Life Orientation Test (LOT-R)
8. 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.
