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

Mount Sinai Hospital, Canada

Status: Completed

Conditions: Infertility, Male; DNA Damage

Treatments: Procedure: Intracytoplasmic sperm injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02058082

Sperm DNA damage study

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

ejaculated sperm

Active Comparator group

Description:

Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm

Treatment:

Procedure: Intracytoplasmic sperm injection

testicular extracted sperm

Active Comparator group

Description:

Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm

Treatment:

Procedure: Intracytoplasmic sperm injection