Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance

Leukemia Clinical Trial

Official title:

Cross-Sectional Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581646
• Other study ID #: 06-110
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: July 7, 2015
• Start date: September 2006
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study aims to learn about the needs and feelings of women who are infertile. Being infertile means not being able to have a child without the help of a third party. There are other options for building a family. The researchers are interested in the participants' thoughts about these options and want to learn about the experiences of infertile women due to cancer treatment as well as women who are infertile due to other causes. The researchers hope that what they learn will allow them to better care for infertile women in the future.

Description:

As part of this study, you will be asked to fill out a series of questionnaires. These questions will ask about your feelings, sexual function, quality of life, and ideas about reproductive options. We will also ask some questions about you, your health, and your medical history. You can choose to answer these questions either at one of your doctor visits or over the telephone. You can decide the best way to complete this assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

Study group of gynecologic cancer survivors and BMT/SMT cancer survivors:

• History of a primary diagnosis of gynecologic cancer or history of any primary malignancy treated with BMT/SCT

• No evidence of disease for at least one year

• At least 18 years of age not greater than 49 years of age at time of study recruitment

• No other cancer history

• Have impaired fertility: lack of uterus but intact ovaries or lack of ovaries or lack of ovarian function based on the FSH determination but intact uterus

• Have not started or have not completed childbearing

• Able and willing to provide informed consent

• Ability to comprehend and complete questionnaire in English

Comparison Group of non-cancer infertile women awaiting egg (oocyte) donation:

• No cancer history

• At least 18 years of age not greater than 49 years of age at time of study recruitment

• In ovarian failure and on a waiting list for egg (oocyte) donation

• Have not started or have not completed childbearing

• Able and willing to provide informed consent

• Ability to comprehend and complete questionnaire in English

Exclusion Criteria:

• Inability to participate in an informed consent process

• Patients with a psychiatric disorder precluding response to the survey

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Infertility
• Leukemia
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms

Intervention

Behavioral:
• survey instrument
Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone. We expect the study survey to take approximately 35-45 minutes to complete. The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate emotional, sexual functioning, reproductive concerns and QOL experience of 3 groups of infertile women: gynecologic cancer survivors, survivors of hematological malignancies, & the non-cancer infertile women awaiting 3rd party reproduction		2 years	No
Secondary	Assess and describe the attitudes towards, knowledge of, and utilization of third party reproduction of the study participants (cancer and non-cancer infertile groups)		2 years	No
Secondary	Compare the main domains of depression, distress, sexual functioning and overall QOL of the gynecologic cancer survivors and survivors of a hematological malignancy with history of BMT/SCT to non-cancer infertile women awaiting third party reproduction		2 years	No

External Links

•   Memorial Sloan Kettering Cancer Center