NCT01461395

Brief Summary

The purpose of this study is to find a non-invasive way to discover DNA (deoxyribonucleic acid, which is the genetic material inside your cells) alterations in the sperm's head, in the near future leading us to choose the "good sperm" in a simplified manner. This could then increase chances of a successful in-vitro fertilization (IVF) treatment when there are sperm abnormalities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Typical duration 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

October 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

3.7 years

First QC Date

February 2, 2011

Last Update Submit

August 23, 2012

Conditions

DNA DamageOther Complications Associated With Artificial Fertilization

Keywords

IVF

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

IVF patients already undergoing therapy and providing a semen sample for sperm count

You may qualify if:

  • Age 18-60 years
  • provide informed consent
  • Already providing a semen sample as routine therapy in IVF

You may not qualify if:

  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida South Tampa Center

Tampa, Florida, 33606, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

sperm

Study Officials

  • Celso Silva, M.D

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2011

First Posted

October 28, 2011

Study Start

October 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

US(1)