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

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058082
• Other study ID #: Sperm DNA damage study
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: February 6, 2014
• Start date: June 2005
• Est. completion date: December 2011

Study information

• Verified date: February 2014
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• DNA Damage
• Infertility
• Infertility, Male

Intervention

Procedure:
• Intracytoplasmic sperm injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rates		Up to 1 year	No
Secondary	sperm DNA damage		Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure	No
Secondary	oocyte fertilization rates		at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)	No
Secondary	embryo cleavage rate		Day 3 post oocytes retrieval	No
Secondary	blastocyst rate		Day 5 post oocytes retrieval	No
Secondary	pregnancy rate	Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound	6 to 8 week ultrasound	No
Secondary	rate of spontaneous abortion		after a clinical pregnancy has been established, up to 10 months after procedure	No
Secondary	birth defects		1-year following delivery	No