InfertilityNCT02756325
Quantitative MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male
A study testing MRI in people with Infertility, run by NYU Langone Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infertility
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with normospermia who are initiating testosterone replacement and are over 18 years of age will provide semen samples to NYU Fertility Center.
Who cannot join
- 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.
About this study
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.
- Conditions
- Infertility
- Being tested
- MRI
- Keywords
- Azoospermia, IVF, MRI
- Medical subject headings
- Infertility, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
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
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Not described Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testis Function from Quantitative MRI
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2019
- Study completionJan 2019
Why it stopped: PI is no longer with the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Alukal, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756325
- Sponsor's protocol ID
- 14-01637
- Status last verified
- Jan 2019
- First submitted
- 28 Apr 2016
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male
- ClinicalTrials.gov ID
- NCT02756325
- Acronym / sponsor ID
- 14-01637
- Conditions
- Infertility
- Keywords
- Azoospermia, IVF, MRI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is no longer with the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Device: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with normospermia who are initiating testosterone replacement and are over 18 years of age will provide semen samples to NYU Fertility Center.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIImaging 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 | Device | MRI |
Primary outcome
Testis Function from Quantitative MRI
Time frame: Six Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Alukal, MD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Infertility, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testis Function from Quantitative MRI (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.