Impact of Sperm DNA Integrity on In Vitro Cycles

Completed

• Conditions: Unexplained Infertility; Abortion, Habitual; Male Infertility

• Registration Number: NCT01232465
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-02
• Primary Completion: 2013-02
• Study Completion: 2013-09
• Results First Submitted: 2014-01-21
• Results First Submitted QC: 2014-01-21
• Status Verified: 2014-03
• Results First Posted: 2014-03-06
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 420

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy	9 months	detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth

Trial Locations

Locations (1)

Center for Human Reproduction; 🇺🇸 Manhasset, New York, United States