Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation
March 4, 2015 updated by: Bruce Shapiro M.D.
We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome.
Study Overview
Detailed Description
A "SpermComet" assay will be used to characterize DNA fragmentation of surplus sperm samples remaining after in vitro fertilization (IVF) cycles.
We will investigate potential correlation between these assay results and the outcomes of IVF cycles that used those sperm samples.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nevada
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Las Vegas, Nevada, United States, 89117
- Fertility Center of Las Vegas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Couples who undergoing IVF treatment who have surplus sperm available after oocyte insemination.
Description
Inclusion Criteria:
- Undergoing IVF
- Surplus sperm available after oocyte insemination
- Consented
Exclusion Criteria:
- Surgical sperm extraction
- Use of donated sperm or oocytes
- No minors may participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SpermComet Assay
All study subjects will have their surplus sperm analyzed for DNA fragmentation with the SpermComet assay.
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Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blastulation rate
Time Frame: 6 days
|
The proportion of oocytes and of fertilized oocytes that form blastocysts.
|
6 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fertilization rate
Time Frame: 1 day
|
Proportion of inseminated oocytes that form exactly two pronuclei.
|
1 day
|
|
Embryo grade
Time Frame: 6 days
|
Grade and measurements of blastocysts that form.
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruce Shapiro, MD, PhD, Fertility Center of Las Vegas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
January 7, 2014
First Submitted That Met QC Criteria
January 7, 2014
First Posted (Estimate)
January 9, 2014
Study Record Updates
Last Update Posted (Estimate)
March 6, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAIRB-13-0038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.