Prospective Observational Correlation of Sperm Assay Resu... | NCT02031549

Studies
Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

NCT02031549

Sponsor

Bruce Shapiro M.D.

Status

Completed

Last Update Posted

Mar 6, 2015Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Infertility

Interventions

SpermComet assay

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Feb 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jan 7, 2014

First Submission Date that Met QC Criteria

Jan 7, 2014

First Posted Date

Jan 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2015

Last Update Posted Date

Mar 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SpermComet Assay		All study subjects will have their surplus sperm analyzed for DNA fragmentation with the SpermComet assay.	Other: SpermComet assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SpermComet assay	Other	Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).	SpermComet Assay

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blastulation rate	The proportion of oocytes and of fertilized oocytes that form blastocysts.	6 days

Secondary Outcomes

Measure	Description	Time Frame
Fertilization rate	Proportion of inseminated oocytes that form exactly two pronuclei.	1 day
Embryo grade	Grade and measurements of blastocysts that form.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Couples who undergoing IVF treatment who have surplus sperm available after oocyte insemination.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce Shapiro, MD, PhD	Fertility Center of Las Vegas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertility Center of Las Vegas		Las Vegas	Nevada	89117	United States

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided