跳至主要内容
临床试验/NCT02756325
NCT02756325撤回不适用

Quantitative MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male

NYU Langone Health0 个研究点开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Testis Function from Quantitative MRI

研究概览

简要总结

Infertility-the inability to conceive despite one year of properly timed unprotected intercourse-is a common problem. Of all types of male factor infertility, non-obstructive azoospermia may be the most difficult for couples. Importantly, patients with non-obstructive azoospermia are asked to make difficult decisions in terms of reproductive choice; surgical attempts at identifying sperm (microdissection testicular sperm extraction) are often offered to these patients without a guarantee of being able to identify sperm. New methodologies in terms of evaluation of azoospermic males PRIOR to the couple embarking upon IVF are needed urgently. The other potential benefit of non-invasive determination of testis function and spermatogenesis would be the potential targeting of sperm extraction procedures. We hypothesize that quantitative MRI employing advanced functional metrics will be sensitive to functional and metabolic differences between subsets of azoospermic cases and will improve upon current characterization of patients with this condition. Moreover, it is believed that these techniques will provide complementary information, such that they may be combined in a synergistic fashion for targeted extraction methodologies.

详细描述

Of all types of male factor infertility, non-obstructive azoospermia may be the most difficult for couples. Azoospermia (both obstructive and non-obstructive) occurs in approximately 10-20% of all infertile males with non-obstructive azoospermia encompassing the majority of cases.

In this study, quantitative MRI will be investigated by employing advanced functional metrics for addressing these challenges. Specifically, diffusion-weighted imaging will be assessed, multi-echo T2 mapping, arterial-spin labeling, and spectroscopy. No intravenous contrast will be administered for purposes of this study. It is hypothesized that these techniques will be sensitive to functional and metabolic differences between subsets of azoospermic cases and will improve upon current characterization of patients with this condition. Moreover, it is believed that these techniques will provide complementary information, such that they may be combined in a synergistic fashion for targeted extraction methodologies.

The goal of this exploratory study is to investigate whether associations exist between quantitative MRI metrics and the previously noted features of testis architecture.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Men with normospermia who are initiating testosterone replacement and are over 18 years of age will provide semen samples to NYU Fertility Center.

排除标准

  • •Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.
  • •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study.
  • •All women are excluded as such patients do not have the relevant anatomy being considered in this study.

研究组 & 干预措施

MRI

Experimental

干预措施: MRI (Device)

结局指标

主要结局

Testis Function from Quantitative MRI

时间窗: Six Months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验