Impact of Sperm DNA Integrity on In Vitro Cycles

Male Infertility Clinical Trial

— TBA on IVF  

Official title:

Impact of Sperm DNA Integrity on In Vitro Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232465
• Other study ID #: 10-249A
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: March 14, 2014
• Start date: October 2010
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: September 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• couple undergoing IVF at the Center for Human Reproduction

• sperm sample given from partner (not a donor)

Exclusion Criteria:

• low sperm concentration (<5 million/cc)

• using a donor sample

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Abortion, Habitual
• Infertility
• Infertility, Male
• Male Infertility
• Unexplained Infertility

Locations

Country	Name	City	State
United States	Center for Human Reproduction	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Epub 2007 Jul 20. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Jul 22. — View Citation

Schlegel PN, Paduch DA. Yet another test of sperm chromatin structure. Fertil Steril. 2005 Oct;84(4):854-9. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Zini A, Libman J. Sperm DNA damage: clinical significance in the era of assisted reproduction. CMAJ. 2006 Aug 29;175(5):495-500. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy	detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth	9 months	No