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

NCT ID: NCT02058082

Last Updated: 2014-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Infertility, Male DNA Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ejaculated sperm

Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm

Group Type ACTIVE_COMPARATOR

Intracytoplasmic sperm injection

Intervention Type PROCEDURE

testicular extracted sperm

Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm

Group Type ACTIVE_COMPARATOR

Intracytoplasmic sperm injection

Intervention Type PROCEDURE

Interventions

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Intracytoplasmic sperm injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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Kirk Lo

Associate Professor, Division Urology Mount Sinai Hospital, University Toronto

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kirk C. Lo, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Other Identifiers

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Sperm DNA damage study

Identifier Type: -

Identifier Source: org_study_id

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