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Withdrawn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
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring Azoospermia, IVF, MRI
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.
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
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Withdrawn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
We'll reach out to this number within 24 hrs