InfertilityNCT02031549
Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation
An observational study of Infertility, run by Bruce Shapiro M.D. at 1 site in United States.
Trial summary
We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- SpermComet assay
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Couples who undergoing IVF treatment who have surplus sperm available after oocyte insemination.
Who may be able to join
- Undergoing IVF
- Surplus sperm available after oocyte insemination
- Consented
Who cannot join
- Surgical sperm extraction
- Use of donated sperm or oocytes
- No minors may participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117
About this study
We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome.
Read the 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.
- Conditions
- Infertility
- Being tested
- SpermComet assay
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpermComet assayOther
Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).
| Study group | Role | What they receive |
|---|---|---|
| SpermComet Assay | All study subjects will have their surplus sperm analyzed for DNA fragmentation with the SpermComet assay. Receives: Other: SpermComet assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation rate
The proportion of oocytes and of fertilized oocytes that form blastocysts.
Measured: 6 days
Secondary outcomes (2)
Fertilization rate
Proportion of inseminated oocytes that form exactly two pronuclei.
Measured: 1 day
Embryo grade
Grade and measurements of blastocysts that form.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruce Shapiro M.D.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Bruce Shapiro M.D., Fertility Center of Las Vegas
- Investigators
- Bruce Shapiro, MD, PhD, Principal investigator, Fertility Center of Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031549
- Sponsor's protocol ID
- SAIRB-13-0038
- Status last verified
- Mar 2015
- First submitted
- 7 Jan 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation
- ClinicalTrials.gov ID
- NCT02031549
- Acronym / sponsor ID
- SAIRB-13-0038
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bruce Shapiro M.D.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpermComet Assay | – | Other: SpermComet assayAll study subjects will have their surplus sperm analyzed for DNA fragmentation with the SpermComet assay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Couples who undergoing IVF treatment who have surplus sperm available after oocyte insemination.
Key inclusion criteria (3 listed)
- Undergoing IVF
- Surplus sperm available after oocyte insemination
- Consented
Key exclusion criteria (3 listed)
- Surgical sperm extraction
- Use of donated sperm or oocytes
- No minors may participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpermComet assayMeasurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention). | Other | SpermComet Assay |
Primary outcome
Blastulation rate
Time frame: 6 days
The proportion of oocytes and of fertilized oocytes that form blastocysts.
2 secondary outcomes
Fertilization rate
Time frame: 1 day
Embryo grade
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Shapiro, MD, PhD principal investigator
Fertility Center of Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Bruce Shapiro M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastulation rate (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.