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recruitment issues
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The primary objective of this study is to determine if the use of frozen surgical testicular sperm specimens for ICSI lead to different IVF outcomes when compared with the use of fresh surgical testicular sperm for ICSI.
The study seeks to isolate the effect of slow freezing and thawing of surgical sperm specimens on fertilization and embryo blastulation rates by utilizing a randomized controlled split cohort protocol including men with obstructive azoospermia undergoing surgical sperm retrieval and good-prognosis female patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresh surgical testicular sperm | No Intervention | Fresh, surgically obtained testicular sperm | |
| Frozen surgical testicular sperm | Experimental | Surgically obtained testicular sperm that will undergo slow freezing and thawing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow Freezing and Thawing | Other | half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blastulation Rate | total number of embryos reaching the blastulation stage of development | 5-7 days post ICSI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization Rate | number of 2PNs | 1 day post ICSI |
| Time to Find Sperm in Fresh Specimen | total amount of time spent finding sperm in the fresh surgical testicular sperm sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Tiegs, MD | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey | 07920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12893345 | Background | Levine LA, Dimitriou RJ, Fakouri B. Testicular and epididymal percutaneous sperm aspiration in men with either obstructive or nonobstructive azoospermia. Urology. 2003 Aug;62(2):328-32. doi: 10.1016/s0090-4295(03)00374-1. | |
| 27894976 | Background | Cui X, Ding P, Gao G, Zhang Y. Comparison of the Clinical Outcomes of Intracytoplasmic Sperm Injection Between Spermatozoa Retrieved From Testicular Biopsy and From Ejaculate in Cryptozoospermia Patients. Urology. 2017 Apr;102:106-110. doi: 10.1016/j.urology.2016.08.071. Epub 2016 Nov 25. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| up to 6 hours post surgery |
| Post-thaw recovery rate of frozen surgical sperm | analysis of sperm parameters post freezing | 30 minutes after freezing |
| Aneuploidy Rate | number of chromosomally normal and abnormal embryos | 2 weeks post trophectoderm biopsy |
| Implantation Rate | presence of fetal heart beat at discharge to obstetric care | approximately 4-6 weeks post embryo transfer |
| 23490166 | Background | Ben-Ami I, Raziel A, Strassburger D, Komarovsky D, Ron-El R, Friedler S. Intracytoplasmic sperm injection outcome of ejaculated versus extracted testicular spermatozoa in cryptozoospermic men. Fertil Steril. 2013 Jun;99(7):1867-71. doi: 10.1016/j.fertnstert.2013.02.025. Epub 2013 Mar 13. |
| 27108915 | Background | Pabuccu EG, Caglar GS, Tangal S, Haliloglu AH, Pabuccu R. Testicular versus ejaculated spermatozoa in ICSI cycles of normozoospermic men with high sperm DNA fragmentation and previous ART failures. Andrologia. 2017 Mar;49(2). doi: 10.1111/and.12609. Epub 2016 Apr 25. |
| 24345355 | Background | Ohlander S, Hotaling J, Kirshenbaum E, Niederberger C, Eisenberg ML. Impact of fresh versus cryopreserved testicular sperm upon intracytoplasmic sperm injection pregnancy outcomes in men with azoospermia due to spermatogenic dysfunction: a meta-analysis. Fertil Steril. 2014 Feb;101(2):344-9. doi: 10.1016/j.fertnstert.2013.10.012. Epub 2013 Dec 9. |
| 22608316 | Background | Forman EJ, Li X, Ferry KM, Scott K, Treff NR, Scott RT Jr. Oocyte vitrification does not increase the risk of embryonic aneuploidy or diminish the implantation potential of blastocysts created after intracytoplasmic sperm injection: a novel, paired randomized controlled trial using DNA fingerprinting. Fertil Steril. 2012 Sep;98(3):644-9. doi: 10.1016/j.fertnstert.2012.04.028. Epub 2012 May 17. |