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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IntelliWell Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of IntelliWell to identify and localize sperm for ICSI | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm detection rate by IntelliWell (sperm/min) | Date of surgery and date of ICSI | |
| Sperm retrieval success rate | Defined as at least one ICSI-grade sperm retrieved from IntelliWell | Date of surgery and date of ICSI |
| Measure | Description | 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 | |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Kathrins, MD | Contact | 617-732-6227 | mkathrins@bwh.harvard.edu | |
| Siline Thai | Contact | 617-525-8793 | sthai1@bwh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28483505 | Background | Kathrins M, Abhyankar N, Shoshany O, Liebermann J, Uhler M, Prins G, Niederberger C. Post-thaw recovery of rare or very low concentrations of cryopreserved human sperm. Fertil Steril. 2017 Jun;107(6):1300-1304. doi: 10.1016/j.fertnstert.2017.04.016. Epub 2017 May 5. | |
| 26263080 | Background | Bernie AM, Mata DA, Ramasamy R, Schlegel PN. Comparison of microdissection testicular sperm extraction, conventional testicular sperm extraction, and testicular sperm aspiration for nonobstructive azoospermia: a systematic review and meta-analysis. Fertil Steril. 2015 Nov;104(5):1099-103.e1-3. doi: 10.1016/j.fertnstert.2015.07.1136. Epub 2015 Aug 8. |
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|
| 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 |
| 32793376 | Background | Berger AJ, Raup V, Abou Ghayda R, Lanes A, Kathrins M. Inability to obtain sperm for fresh IVF cycles: analysis and incidence of outcomes using a database from the United States. Fertil Res Pract. 2020 Aug 11;6:14. doi: 10.1186/s40738-020-00082-3. eCollection 2020. |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D053713 | Azoospermia |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D020554 | Sperm Injections, Intracytoplasmic |
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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