Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage

Not Applicable

Completed

• Conditions: DNA Damage; Infertility, Male

• Registration Number: NCT02058082
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief Summary

The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2011-01
• Study Completion: 2011-12
• Study First Submitted: 2014-01-27
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Study First Posted: 2014-02-07
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• ≥18 years of age
• be considered infertile (>1 year of unsuccessful attempts of conception
• Any race
• Male partner with persistent sperm DNA damage, DFI>=30%
• candidates for intracytoplasmic sperm injection (ICSI)

Exclusion Criteria

• significant female factor infertility contributing to the couple's infertility
• female partner older than 38 years
• male or female patients with genetic abnormalities
• patients unable or unwilling to give consent after properly informed
• couples unsuitable for IVF/ICSI
• male patients in whom testicular procedures were contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Live birth rates	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
sperm DNA damage	Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
pregnancy rate	6 to 8 week ultrasound	Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound
rate of spontaneous abortion	after a clinical pregnancy has been established, up to 10 months after procedure
embryo cleavage rate	Day 3 post oocytes retrieval
blastocyst rate	Day 5 post oocytes retrieval
oocyte fertilization rates	at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
birth defects	1-year following delivery