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WithdrawnNCT02756325Updated Jan 29, 2019

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

An interventional study of MRI in Infertility, sponsored by NYU Langone Health. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-29.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
PI is no longer with the institution
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Infertility

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Keywords

  • Azoospermia, IVF, MRI
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

Browse Infertility studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    MRI

    Device: MRI

Interventions

  • DeviceMRI

    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

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What researchers measure

Primary outcomes

  1. Testis Function from Quantitative MRI

    Time frame: Six Months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02756325
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Apr 29, 2016
Start date
Jun 2016
Primary completion
Jan 2019
Completion
Jan 2019
Last update
Jan 29, 2019

Study contacts

Joseph Alukal, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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