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NCT Number: NCT00581646

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

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.

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Key information

Conditions

Cervical Cancer Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infertility Leukemia Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non-Hodgkin's Lymphoma Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

survey instrument

Behavioral

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.

Primary outcomes

  1. 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

    Time frame: 2 years

Secondary outcomes

  1. Assess and describe the attitudes towards, knowledge of, and utilization of third party reproduction of the study participants (cancer and non-cancer infertile groups)

    Time frame: 2 years

  2. 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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • New York Presbyterian Hospital

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Dec 28, 2007
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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