Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage
Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage
1 other identifier
interventional
25
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2005
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 27, 2014
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedFebruary 7, 2014
February 1, 2014
5.6 years
January 27, 2014
February 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rates
Up to 1 year
Secondary Outcomes (7)
sperm DNA damage
Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
oocyte fertilization rates
at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
embryo cleavage rate
Day 3 post oocytes retrieval
blastocyst rate
Day 5 post oocytes retrieval
pregnancy rate
6 to 8 week ultrasound
- +2 more secondary outcomes
Study Arms (2)
ejaculated sperm
ACTIVE COMPARATORIntracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm
testicular extracted sperm
ACTIVE COMPARATORIntracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm
Interventions
Eligibility Criteria
You may qualify if:
- ≥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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kirk C. Lo, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Division Urology Mount Sinai Hospital, University Toronto
Study Record Dates
First Submitted
January 27, 2014
First Posted
February 7, 2014
Study Start
June 1, 2005
Primary Completion
January 1, 2011
Study Completion
December 1, 2011
Last Updated
February 7, 2014
Record last verified: 2014-02