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临床试验/NCT02515916
NCT02515916终止不适用

Fertility Preservation- Oncology Treatment Effects and Psychological Impact

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
AMH (anti-mullerian hormone) blood levels

研究概览

简要总结

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).

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women ages 18-45
  • Women seeking fertility preservation at WCMC
  • Women who will undergo oncology treatments that will likely cause reduced fertility potential.

排除标准

  • Women who do not meet the inclusion criteria

结局指标

主要结局

AMH (anti-mullerian hormone) blood levels

时间窗: Up to 3 years

To determine if fertility reserve is affected by oncology treatment.

Quality of life on the Dyadic Adjustment Scale

时间窗: 3 years

To determine if there is any psychological impact of oncology treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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