NCT02031549

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

January 7, 2014

Last Update Submit

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

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Bruce Shapiro, MD, PhD

    Fertility Center of Las Vegas

    PRINCIPAL INVESTIGATOR

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 1, 2014

Primary Completion

February 1, 2014

Study Completion

April 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(1)