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| Tracking Information | |||||
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| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | August 12, 2009 | ||||
| Start Date ICMJE | September 2006 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Investigate emotional, sexual functioning, reproductive concerns and qol experience of 3 groups of infertile women:gyn cancer survivors, survivors of hematological malig, & the noncancer infertile women awaiting 3rd party reproduction. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00581646 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance | ||||
| Official Title ICMJE | Cross-Sectional Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance | ||||
| Brief 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. |
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| Detailed 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: survey instrument | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 170 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Study group of gynecologic cancer survivors and BMT/SMT cancer survivors:
Comparison Group of non-cancer infertile women awaiting egg (oocyte) donation:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 49 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00581646 | ||||
| Responsible Party | Jeanne Carter, Ph.D, Memorial Sloan-Kettering Cancer Center | ||||
| Study ID Numbers ICMJE | 06-110 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | New York Presbyterian Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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