Back to resultsTesticular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage
Primary Purpose
Infertility, Male, DNA Damage
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intracytoplasmic sperm injection
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Male focused on measuring Failure to Conceive Due to Infertility of Male Partner, DNA Damage
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ejaculated sperm
testicular extracted sperm
Arm Description
Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm
Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm
Outcomes
Primary Outcome Measures
Live birth rates
Secondary Outcome Measures
sperm DNA damage
oocyte fertilization rates
embryo cleavage rate
blastocyst rate
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
rate of spontaneous abortion
birth defects
Full Information
NCT ID
NCT02058082
First Posted
January 27, 2014
Last Updated
February 6, 2014
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02058082
Brief Title
Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male, DNA Damage
Keywords
Failure to Conceive Due to Infertility of Male Partner, DNA Damage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ejaculated sperm
Arm Type
Active Comparator
Arm Description
Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm
Arm Title
testicular extracted sperm
Arm Type
Active Comparator
Arm Description
Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm
Intervention Type
Procedure
Intervention Name(s)
Intracytoplasmic sperm injection
Primary Outcome Measure Information:
Title
Live birth rates
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
sperm DNA damage
Time Frame
Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
Title
oocyte fertilization rates
Time Frame
at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
Title
embryo cleavage rate
Time Frame
Day 3 post oocytes retrieval
Title
blastocyst rate
Time Frame
Day 5 post oocytes retrieval
Title
pregnancy rate
Description
Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound
Time Frame
6 to 8 week ultrasound
Title
rate of spontaneous abortion
Time Frame
after a clinical pregnancy has been established, up to 10 months after procedure
Title
birth defects
Time Frame
1-year following delivery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk C. Lo, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage
We'll reach out to this number within 24 hrs