Impact of Sperm DNA Integrity on In Vitro Cycles

NCT01232465 | Completed Results

• 1 other identifier: 10-249A
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Male Infertility; Unexplained Infertility; Abortion, Habitual

Keywords

sperm DNA integrity; Toluidine blue assay (TBA); IVF outcome

Outcome Measures

Primary Outcomes (1)

• Pregnancy

  detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth

  9 months

Study Arms (2)

IVF

those individuals undergoing conventional IVF to inseminate their retrieved eggs

ICSI

those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

couples undergoing IVF treatement at the Center for Human Reproduction, North Shore University Hospital, Manhasset NY

You may qualify if:

• couple undergoing IVF at the Center for Human Reproduction
• sperm sample given from partner (not a donor)

You may not qualify if:

• low sperm concentration (\<5 million/cc)
• using a donor sample

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Center for Human Reproduction

Manhasset, New York, 11303, United States

Location

Related Publications (12)

• 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.

  PMID: 7558384 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.

  PMID: 12596248 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.

  PMID: 11191087 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.

  PMID: 15271869 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.

  PMID: 16213834 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.

  PMID: 17644094 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.

  PMID: 20447937 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.

  PMID: 17579991 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.

  PMID: 16940270 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.

  PMID: 15154089 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.

  PMID: 20495207 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.

  PMID: 19304993 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

slide smears will be kept to observe overall DNA integrity of sperm sample

MeSH Terms

Conditions

Infertility, Male; Abortion, Habitual

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Results Point of Contact

• Title: Dennis Marchesi
• Organization: North Shore

dmarches@nshs.edu

516-562-1761

Study Officials

• Avner E Hershlag, MD

  Center for Human Reproduction

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 11, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-03

Locations

US (1)