An interventional study of mTESE in Non-obstructive Azoospermia, sponsored by Mount Sinai Hospital, Canada. Status unknown at 3 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Mount Sinai Hospital, Canada · Not applicable, Interventional, and Basic science
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Among 58 studies in Infertility, Male with a site in United States — 12 open to participants now, 16 under way, 1 of them phase 3. Infertility, Male · United States.
Among the 58 studies in Infertility, Male with a site in United States, this one is the 6th largest by enrollment of the 36 interventional ones that give a count, is one of 3 that started in 2016, is one of 21 with no phase, and was the 20th registered.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
Browse Infertility, Male studies →12 of the 58 studies in Infertility, Male with a site in United States are open now. Recruiting first, the newest first:
Reproductive Medicine Associates of New Jersey · Sites in United States
Men only
CellARTs Inc. · Sites in United States
Ages 18–60 · Men only · Healthy volunteers
University of Miami · Sites in United States
Ages 18+ · Men only
University of Pittsburgh · Sites in United States
Men only
The Bird and Be Co Inc · Sites in United States
Ages 18–50 · Men only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 40 Infertility, Male studies recruiting now, 16 (40%) set no upper age limit and 24 (60%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
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58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 3 · Phase 4 1
First in 2000; this study’s year is marked. 3 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 200 is above the median of 80 across 187 interventional studies indexed under Infertility, Male.
Median enrollment 58 across the 36 interventional studies, 215 across the 22 observational. Of the 35 that completed or were terminated, 17 (49%) have results posted.
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17 of 58 have an industry lead sponsor. The 10 most frequent:
Mount Sinai Hospital, Canada is the lead sponsor of 158 studies on the registry; 32 are open to participants now.
Mount Sinai Hospital, Canada has 3 studies filed under Infertility, Male — fewer than ten, so there is no comparison to draw.
7 of the studies in Infertility, Male with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05903859Phase 3University of MiamiImprovement of Reproductive Function in Men With Spinal Cord Injury (SCI) | 2027-05-31 |
| NCT06566599Inception Fertility Research Institute, LLCPreimplantation Genetic Testing for Aneuploidy (PGT-A) in Couples With Non-obstructive Azoospermia (NOA) | 2026-12 |
| NCT06841861CellARTs Inc.Spermatogonial Differentiation Via Testicular Organoid | 2026-12-01 |
| NCT05479474Stanford UniversityPlatelet Rich Plasma Testis Treatment for Infertile Men | 2026-12-31 |
| NCT05951075The Bird and Be Co IncProspective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results | 2026-12-31 |
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Among the 58 studies in Infertility, Male with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The investigators hypothesize that sperm production varies with time in men with no sperm in semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to monitor these changes. The investigators further hypothesize that TEX101 levels may be used to predict the optimum time for microsurgical testicular sperm extraction (mTESE) to provide the highest successful rates of sperm retrieval.
This is a non-randomized pilot study. All men with NOA, who may or may not consider having mTESE, will be approached to enter this study.
Recruited men will have a semen test performed at the initial visit (time 0) to measure semen TEX101 levels using an ELISA assay.
For men who are not considering a mTESE to retrieve sperm, the TEX101 semen levels will be measured monthly for three months to determine the variability of semen TEX101.
For men who are considering a mTESE in an attempt to retrieve sperm, the mTESE procedure to retrieve sperm will be booked. If the level of TEX101 is detectable at time 0, then the men will have semen testing monthly. If the TEX101 is persistently detectable then the men will have surgery at the time originally scheduled. If the TEX101 drops on any subsequent test to be undetectable, then the semen testing for TEX101 will continue monthly for a maximum of 3 additional months. If the TEX101 remains undetectable for all tests, the men will have the mTESE at the end of the additional 3 months. If the TEX101 is detectable on a subsequent test, then the men will undergo an immediate mTESE (\< 2 weeks).
If the initial TEX101 is undetectable, then the men will have monthly semen testing for TEX101 for a maximum of 3 additional tests. If the TEX101 remains persistently undetectable, then a mTESE will be performed as originally booked. If the TEX101 is detected on a subsequent test, then an immediate mTESE (\< 2 weeks) is performed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is a single arm study. All patients will be asked to provide multiple semen samples and all samples will be tested with TEX101 ELISA assay. Timing of mTESE maybe changed according to the assay results.
Procedure: mTESE
mTESE time may be postponed or advanced.
Successful testicular sperm retrieval
This outcome will be measured by if sperms would be found during the procedure or if sperms would be identified in the IVF clinic.
Time frame: 2 years
Natural variation in sperm counts in semen
Variation in sperm concentration in semen as measured by direct microscopic assessment of different semen samples provided by each of the participants.
Time frame: 2 years
Natural variation in semen TEX101 concentration
Variation in TEX101 concentrations in semen of different semen samples provided by each of the participants as measured by the TEX101 ELISA assay.
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Feb 2016, a primary completion of Dec 2019 and a completion of Dec 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Mount Sinai Hospital, Canada →