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

Not Applicable

Completed

• Conditions: DNA Damage; Infertility, Male
• Interventions: Procedure: Intracytoplasmic sperm injection

• 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

Arm && Interventions

Group	Intervention	Description
ejaculated sperm	Intracytoplasmic sperm injection	Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm
testicular extracted sperm	Intracytoplasmic sperm injection	Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm

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
birth defects	1-year following delivery
oocyte fertilization rates	at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)