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Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVF | those individuals undergoing conventional IVF to inseminate their retrieved eggs | ||
| ICSI | those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy | detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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couples undergoing IVF treatement at the Center for Human Reproduction, North Shore University Hospital, Manhasset NY
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| Name | Affiliation | Role |
|---|---|---|
| Avner E Hershlag, MD | Center for Human Reproduction | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Human Reproduction | Manhasset | New York | 11303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7558384 | Background | Andreetta AM, Stockert JC, Barrera C. A simple method to detect sperm chromatin abnormalities: cytochemical mechanism and possible value in predicting semen quality in assisted reproductive procedures. Int J Androl. 1995 Jun;18 Suppl 1:23-8. doi: 10.1111/j.1365-2605.1995.tb00634.x. | |
| 12596248 | Background | Erenpreisa J, Erenpreiss J, Freivalds T, Slaidina M, Krampe R, Butikova J, Ivanov A, Pjanova D. Toluidine blue test for sperm DNA integrity and elaboration of image cytometry algorithm. Cytometry A. 2003 Mar;52(1):19-27. doi: 10.1002/cyto.a.10015. |
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Recruitment occured at the Center for Human Reproduction under an IRB waiver of informed consent for participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | IVF Cycles | those individuals undergoing conventional IVF to inseminate their retrieved eggs |
| FG001 | ICSI | those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVF Cycles | those individuals undergoing conventional IVF to inseminate their retrieved eggs |
| BG001 | ICSI | those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pregnancy | detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth | Posted | Number | participants | 9 months |
|
|
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Measurements of sperm DNA integrity did not have an impact on cycle treatment, failure or success. There were no adverse events in obtaining this data, as the samples were already submitted for clinical purposes. A small aliquat was removed from the clinical sample to generate study data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVF Cycles | those individuals undergoing conventional IVF to inseminate their retrieved eggs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis Marchesi | North Shore | 516-562-1761 | dmarches@nshs.edu |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D000026 | Abortion, Habitual |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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slide smears will be kept to observe overall DNA integrity of sperm sample
| 11191087 | Background | Erenpreiss J, Bars J, Lipatnikova V, Erenpreisa J, Zalkalns J. Comparative study of cytochemical tests for sperm chromatin integrity. J Androl. 2001 Jan-Feb;22(1):45-53. |
| 15271869 | Background | Erenpreiss J, Jepson K, Giwercman A, Tsarev I, Erenpreisa J, Spano M. Toluidine blue cytometry test for sperm DNA conformation: comparison with the flow cytometric sperm chromatin structure and TUNEL assays. Hum Reprod. 2004 Oct;19(10):2277-82. doi: 10.1093/humrep/deh417. Epub 2004 Jul 22. |
| 16213834 | Background | Schlegel PN, Paduch DA. Yet another test of sperm chromatin structure. Fertil Steril. 2005 Oct;84(4):854-9. doi: 10.1016/j.fertnstert.2005.04.050. |
| 17644094 | Background | Collins JA, Barnhart KT, Schlegel PN. Do sperm DNA integrity tests predict pregnancy with in vitro fertilization? Fertil Steril. 2008 Apr;89(4):823-31. doi: 10.1016/j.fertnstert.2007.04.055. Epub 2007 Jul 20. |
| 20447937 | Background | Simon L, Brunborg G, Stevenson M, Lutton D, McManus J, Lewis SE. Clinical significance of sperm DNA damage in assisted reproduction outcome. Hum Reprod. 2010 Jul;25(7):1594-608. doi: 10.1093/humrep/deq103. Epub 2010 May 6. |
| 17579991 | Background | Tarozzi N, Bizzaro D, Flamigni C, Borini A. Clinical relevance of sperm DNA damage in assisted reproduction. Reprod Biomed Online. 2007 Jun;14(6):746-57. doi: 10.1016/s1472-6483(10)60678-5. |
| 16940270 | Background | Zini A, Libman J. Sperm DNA damage: clinical significance in the era of assisted reproduction. CMAJ. 2006 Aug 29;175(5):495-500. doi: 10.1503/cmaj.060218. |
| 15154089 | Background | Sharma RK, Said T, Agarwal A. Sperm DNA damage and its clinical relevance in assessing reproductive outcome. Asian J Androl. 2004 Jun;6(2):139-48. |
| 20495207 | Background | Speyer BE, Pizzey AR, Ranieri M, Joshi R, Delhanty JD, Serhal P. Fall in implantation rates following ICSI with sperm with high DNA fragmentation. Hum Reprod. 2010 Jul;25(7):1609-18. doi: 10.1093/humrep/deq116. Epub 2010 May 22. |
| 19304993 | Background | Tsarev I, Bungum M, Giwercman A, Erenpreisa J, Ebessen T, Ernst E, Erenpreiss J. Evaluation of male fertility potential by Toluidine Blue test for sperm chromatin structure assessment. Hum Reprod. 2009 Jul;24(7):1569-74. doi: 10.1093/humrep/dep068. Epub 2009 Mar 21. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | ICSI | those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI) | 0 | 0 | 0 | 0 |
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| D052801 |
| Male Urogenital Diseases |
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |