An observational study in Non-obstructive Azoospermia and Male Infertility, sponsored by Inception Fertility Research Institute, LLC. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Inception Fertility Research Institute, LLC · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 planned enrollment of the 22 observational ones that give a count, is one of 3 that started in 2024, is one of 22 observational ones, reaches primary completion later than 4 of the 15 other live ones, and was the 53rd 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: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 182 across 87 observational 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.
This tab as a report to print or save as PDF → With an account.
17 of 58 have an industry lead sponsor. The 10 most frequent:
Inception Fertility Research Institute, LLC is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Inception Fertility Research Institute, LLC has 1 study 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 |
Add all 7 to your calendar (.ics) → With an account.
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.
Objective: To examine the rate of embryo aneuploidy in patients with non-obstructive azoospermia (NOA) who utilize in-vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) and compare live birth rates with the utilization of preimplantation genetic testing for aneuploidy (PGT-A) vs non PGT-A.
Preimplantation genetic testing for aneuploidy (PGT-A) facilitates selection of euploid embryos for transfer and may improve outcomes in select couples when the female partner is 35 or older. While embryonic aneuploidy is known to be associated with maternal risk factors such as advanced age, the male factors contributing to aneuploidy are not as clear. Severe male factor infertility is associated with various genetic causes, including karyotypic abnormalities. One retrospective analysis of 668 infertile patients diagnosed with various nonobstructive spermatogenic defects using high resolution Giemsa banding chromosome analysis and/or fluorescence in situ hybridization revealed constitutional chromosomal abnormalities in 55 (8.2%) patients. The observed incidence was almost 20-fold greater than what is reported in healthy fertile men (0.37%). This study correlated cytogenetic aberrations with male reproductive phenotypes and noted that sex chromosome aneuploidy was the most common finding in azoospermia (AS) cases, accounting for about 9%, with Klinefelter syndrome (47, XXY karyotype and variants) accounting for 4% of all infertile males. Notably, the 47, XXY karyotype was detected at a considerably higher rate in men with AS vs oligospermia (OS) (27 of 668 or 9.1% vs 3 of 365 or 0.8%). Little is known about the impact of constitutional aneuploidy on embryonic aneuploidy rates after fertilization with surgically extracted sperm. Another study examined the impact of severe male factor infertility in 326 cycles on aneuploidy in embryos and found significant increases in embryo aneuploidy and higher mosaicism rates in cases using testicular sperm from patients with severe male factor infertility as compared to non-male factor controls. This study found that the statistically significant affected chromosomes were 2, 10, 11, 17, 21 and sex chromosomes. While sperm chromosomal aneuploidy are consistently higher in severe male factor infertility, the impact on IVF outcomes and potential benefits of PGT-A are unclear. Additionally, data on differences in aneuploidy rates between OA and NOA are mixed. Further research is warranted to help facilitate appropriate counseling of affected couples and better understand the role of PGT-A in severe male-factor infertility treatment. We will conduct a retrospective chart review to examine the rates of aneuploidy in embryos resulting from ICSI with surgically extracted sperm in patients with NOA and OA and characterize the chromosomes commonly affected in identified aneuploid embryos.
Couples who have undergone IVF/ICSI with or without pre-implantation genetic testing for aneuploidy (PGT-A) at a fertility clinic in The Prelude Network (US sites only).
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:
Aneuploidy rate
Frequency of aneuploidy result in embryos
Time frame: 1 year
Chromosomes associated with aneuploidy
Compare types of embryonic aneuploidy in male factor patients to advanced maternal age patients
Time frame: 1 year
Live birth rate
The frequency of live birth following embryo transfer.
Time frame: 1 year
Clinical pregnancy rate
The frequency of intrauterine pregnancy (IUP) as confirmed by ultrasound post embryo transfer.
Time frame: 1 year
Fertilization rate
The calculated rate of successful fertilization of egg, defined as presence of 2 pronuclei (2PN) on day 1 check post fertilization, to number of eggs where fertilization was attempted.
Time frame: 1 year
Plan to share: No — IPD will not be available to other researchers.
Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to trackQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Inception Fertility Research Institute, LLC →