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

Primary Purpose

Infertility

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Azoospermia, IVF, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MRI

    Arm Description

    Outcomes

    Primary Outcome Measures

    Testis Function from Quantitative MRI

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2016
    Last Updated
    January 25, 2019
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02756325
    Brief Title
    Quantitative MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male
    Official Title
    Quantitative MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI is no longer with the institution
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    January 2019 (Actual)
    Study Completion Date
    January 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    Azoospermia, IVF, MRI

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MRI
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    MRI
    Intervention Description
    Imaging will be performed using a clinical whole-body MRI and a pelvic phased-array coil. No intravenous contrast will be administered. Sequences will include Diffusion weighted imaging (DWI), T2 mapping, arterial spin labeling, and spectroscopy. The acquisition is expected to take approximately one hour
    Primary Outcome Measure Information:
    Title
    Testis Function from Quantitative MRI
    Time Frame
    Six Months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men with normospermia who are initiating testosterone replacement and are over 18 years of age will provide semen samples to NYU Fertility Center. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joseph Alukal, MD
    Organizational Affiliation
    NYU Langone Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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