20 Participants NeededMy employer runs this trial

IntelliWell for Azoospermia

MK
ST
Overseen BySiline Thai
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new technology, IntelliWell, can detect rare sperm cells in testicular samples typically declared sperm-free. If IntelliWell identifies sperm, these can be used for a procedure called ICSI to assist with conception. The trial seeks men diagnosed with infertility due to non-obstructive azoospermia (a condition where sperm is absent in the semen) who are undergoing specific sperm extraction surgery. If standard processing shows no usable sperm in their samples, IntelliWell will re-evaluate them. As an unphased trial, this study offers participants a unique opportunity to potentially benefit from cutting-edge fertility treatment technology.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the IntelliWell platform is safe for identifying rare sperm cells?

In a previous study, researchers used IntelliWell to identify sperm cells in testicular samples, focusing on those that initially showed no sperm with regular methods. The study reported no safety issues with IntelliWell, suggesting it is well-tolerated. As an AI tool for identifying sperm cells, IntelliWell is less likely to cause physical side effects compared to drug treatments. Participants in earlier studies did not experience any negative effects directly linked to IntelliWell, providing some confidence in its safety for human use.12345

Why are researchers excited about this trial?

Researchers are excited about IntelliWell for azoospermia because it offers a novel approach to treating this condition. Unlike the standard of care, which often involves surgical procedures or hormone therapy, IntelliWell may work by potentially enhancing the natural sperm production process directly. This could provide a less invasive and more targeted option for individuals experiencing azoospermia, addressing the root cause rather than just managing symptoms. If successful, IntelliWell could represent a significant advancement in fertility treatment options.

What evidence suggests that IntelliWell is effective for identifying rare sperm cells in azoospermia?

Studies have shown that IntelliWell, a platform using artificial intelligence, can identify rare sperm cells in testicular samples that initially appear empty. Even when traditional methods fail to detect sperm, IntelliWell can sometimes uncover these hidden cells. Early trials suggest this could enhance the success rate of intracytoplasmic sperm injection (ICSI), a procedure where sperm is injected directly into an egg. In severe male infertility cases, finding even a few sperm can be crucial for conception. Although further research is ongoing, these initial findings offer promise for couples facing fertility challenges.12467

Are You a Good Fit for This Trial?

This trial is for men with infertility due to non-obstructive azoospermia who are having testicular sperm extraction surgery at Brigham and Women's Hospital. It includes those whose samples show no usable sperm by standard methods and would otherwise be discarded.

Inclusion Criteria

I am a man scheduled for sperm extraction surgery at Brigham and Women's Hospital.
I am a male diagnosed with non-obstructive azoospermia seeking treatment at Brigham and Women's or Faulkner.
My sperm extraction surgery did not yield enough usable sperm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Testicular tissue is processed using IntelliWell to identify rare sperm cells

1 day
1 visit (in-person)

ICSI Procedure

If sperm is found and verified, it may be used for intracytoplasmic sperm injection (ICSI)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for outcomes related to sperm retrieval and ICSI success

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IntelliWell

Trial Overview

The study tests IntelliWell, an AI-powered imaging tool, to find rare sperm in testicular tissue that standard analysis missed. If found, these sperm may be used for assisted reproduction (ICSI).

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: IntelliWell ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Citations

IntelliWell: An AI-Assisted Imaging Platform for Detection ...

Instead of discarding testicular tissue which was found to be non-sperm bearing by conventional analysis the testicular tissue will be processed using ...

IntelliWell: An AI-Assisted Imaging Platform for Detection and ...

This study will help determine whether an AI-assisted microwell platform (IntelliWell) can identify rare sperm cells in testicular samples found to not have ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39767586/

Predictors of Successful Testicular Sperm Extraction

Testicular sperm extraction (TESE) combined with intracytoplasmic sperm injection is the primary treatment, but success rates are unpredictable, ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41232659/

Embryological outcomes of using surgical sperm in ...

Secondary outcomes were sperm retrieval rate, clinical pregnancy rate (CPR), pregnancy loss rate, preterm birth rate, infant birthweight and ...

AI-Assisted Sperm Detection for Male Infertility Treatment

Clinical trial testing IntelliWell, an AI system to find rare sperm in severe male infertility cases.

Testicular Evaluation of Azoospermia Using Micro- ...

The investigation is a small feasibility study to determine whether there are imaging features related to the seminiferous tubules in the testes under ...

Use of IntelliWell to identify and localize sperm for ICSI in ...

This study will help determine whether an AI-assisted microwell platform (IntelliWell) can identify rare sperm cells in testicular samples found to not have ...