Azoospermia, Infertility
Conditions
Keywords
infertility, azoospermia, micro-TESE
Brief summary
This study will help determine whether an AI-assisted microwell platform (IntelliWell) can identify rare sperm cells in testicular samples found to not have sperm by conventional analysis. Instead of discarding testicular tissue which was found to be non-sperm bearing by conventional analysis the testicular tissue will be processed using IntelliWell and, if sperm is found and verified by embryologists, it may be used for intracytoplasmic sperm injection (ICSI).
Interventions
DEVICEUse of IntelliWell to identify and localize sperm for ICSI
The experimental arm will have surgically extracted testicular sperm processed with IntelliWell. If identified and confirmed by embryology, cryopreservation of sperm will occur. On day of ICSI, thaw of testicular sperm will occur and be processed by IntelliWell for identification and localization for use in ICSI.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male subjects presenting to Brigham and Women's or Faulkner urology clinic with infertility with clinical non-obstructive azoospermia (clinical diagnosis based on two semen analyses, physical examination, and hormonal testing). 2. Male subjects undergoing micro-surgical testicular sperm extraction surgery at Brigham and Women's Hospital. 3. Surgically extracted sperm which are not found to have clinically usable quantities of sperm after standard of care manual processing for which samples would otherwise be discarded and the procedure deemed unsuccessful.
Exclusion criteria
1\. Female subject (with whom male subjects intends to conceive with surgically extracted sperm) cannot or will not provide her informed consent for study participation. She will undergo ICSI at BWH with BWH embryology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm detection rate by IntelliWell (sperm/min) | Date of surgery and date of ICSI | — |
| Sperm retrieval success rate | Date of surgery and date of ICSI | Defined as at least one ICSI-grade sperm retrieved from IntelliWell |
Secondary
| Measure | Time frame |
|---|---|
| Total number of sperm detected in IntelliWell in fresh sample | Date of surgery |
| Total number of sperm detected by IntelliWell in test-thaw samples | Day of surgery |
| Total number of sperm detected by IntelliWell on day of ICSI | Date of ICSI |
| Time to first sperm detection and time to 10 sperm | Date of surgery and date of ICSI |
| Number of IntelliWell-identified sperm verified by embryology | Date of surgery and date of ICSI |
| Number of sperm retrieved and approved for ICSI | Date of ICSI |
| Total IntelliWell search time | Date of surgery and date of ICSI |
Countries
United States
Contacts
CONTACTMartin Kathrins, MD
CONTACTSiline Thai
Outcome results
None listed