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

NCT02756325 | Withdrawn DMC

• 1 other identifier: 14-01637
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Keywords

Azoospermia, IVF, MRI

Outcome Measures

Primary Outcomes (1)

• Testis Function from Quantitative MRI

  Six Months

Study Arms (1)

MRI

EXPERIMENTAL

Device: MRI

Interventions

MRI DEVICE

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

MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Infertility; Azoospermia

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Infertility, Male; Genital Diseases, Male; Male Urogenital Diseases

Study Officials

• Joseph Alukal, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: April 29, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 29, 2019

Record last verified: 2019-01