NCT02031549

Completed

Prospective Observational Correlation of Sperm Assay Results...

Bruce Shapiro M.D.Source

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Other study identifiers

Sponsor study identifier

SAIRB-13-0038

Study Type

observational

Actual enrollment (reported)

40

Locations

1 country

Sites

1

Timeline

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2014

Actual (reported)

Study Completion

April 2014

Actual (reported)

Brief Summary

We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 40 participants
Study completion date: April 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 7, 2014
Actual (reported)
First Posted
January 9, 2014
Actual (reported)
Primary Completion
February 2014
Actual (reported)
Study Completion
April 2014
Actual (reported)

Last Updated: March 6, 2015
Status Verified: March 2015
Last Update Submitted: March 4, 2015

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

Blastulation rate
The proportion of oocytes and of fertilized oocytes that form blastocysts.
6 days

Secondary Outcomes (2)

Fertilization rate
1 day
Embryo grade
6 days

Study Arms (1)

SpermComet Assay

All study subjects will have their surplus sperm analyzed for DNA fragmentation with the SpermComet assay.

Other: SpermComet assay

Interventions

SpermComet assayOther

Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).

SpermComet Assay

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Undergoing IVF

Sponsors & Collaborators

Bruce Shapiro M.D.
Industrylead

Study Sites (1)

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

Bruce Shapiro, MD, PhD
Fertility Center of Las Vegas
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Medical Director

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

NCT02141685

Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)

Unknown

NCT01184469

Prospective Observational Study of Peri-implantation Serum hCG Levels

Completed

NCT01986374

Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF

Not ApplicableCompleted

NCT01732900

Gene Expression in Cumulus Cells to Predict Pregnancy

Not ApplicableCompleted

NCT01687712

Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF

Phase 3Completed

NCT02000349

Comparison of Frozen-thawed Embryo Transfers and Fresh Embryo Transfers With Whole Chromosome Analysis Using Next Generation Sequencing

Phase 2Unknown

Surplus sperm available after oocyte insemination

Consented

You may not qualify if:

Surgical sperm extraction
Use of donated sperm or oocytes
No minors may participate

Contact the study team to confirm eligibility.

Primary Completion

February 2014

Actual (reported)

Study Completion

April 2014

Actual (reported)

Last Updated

March 6, 2015

Record last verified: 2015-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02031549
Data provider: ClinicalTrials.gov
Source updated: 2015-03-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:14 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

SpermComet Assay

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations