Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage

Mount Sinai Hospital, Canada0 sites25 target enrollmentJune 2005

ConditionsInfertility, Male DNA Damage

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility, Male
Sponsor: Mount Sinai Hospital, Canada
Enrollment: 25
Primary Endpoint: Live birth rates
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

December 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Mount Sinai Hospital, Canada

Responsible Party

Principal Investigator

Kirk Lo

Associate Professor, Division Urology Mount Sinai Hospital, University Toronto

Mount Sinai Hospital, Canada

Eligibility Criteria

Inclusion Criteria

•≥18 years of age
•be considered infertile (\>1 year of unsuccessful attempts of conception
•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

Outcomes

Primary Outcomes

Live birth rates

Time Frame: Up to 1 year

Secondary Outcomes

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)
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))