NCT00741494

Brief Summary

The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select sperm for ICSI will result in increased pregnancies especially with men that have a low hyaluronan binding score (HBA).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
801

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

9 active sites

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

August 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

December 28, 2010

Status Verified

December 1, 2010

Enrollment Period

2.3 years

First QC Date

August 25, 2008

Last Update Submit

December 26, 2010

Conditions

Male Factor Infertility

Keywords

infertilityICSIhyaluronan bindingspermsperm selectionmale factorhyaluronansperm maturityclinical pregnancy rateshyaluronan binding assayHBAPICSI

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    8 weeks post ICSI

Study Arms (5)

1

NO INTERVENTION

HBA score over 65% control

2

NO INTERVENTION

HBA score over 65%, non-participant (to even out the participation between patients with low HBA scores and those with high HBA scores)

3

ACTIVE COMPARATOR

HBA score over 65%. PICSI dish is used to select the sperm for ICSI.

Device: PICSI dish

4

EXPERIMENTAL

HBA score less than 65%. PICSI dish used to select sperm for ICSI.

Device: PICSI dish

5

NO INTERVENTION

HBA Score less than 65%. Control

Interventions

PICSI dishDEVICE

Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI

34

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • IVF patients who require the ICSI procedure and whose care is being managed by the clinical and scientific staff of the participating groups, will be included in the study.

You may not qualify if:

  • IVF patients who do not require the ICSI procedure will be excluded from the study. In addition the following groups of patients will also be excluded:
  • Patients using testicular sperm.
  • Patients using donor sperm.
  • Patients where the female partner is over 40 years of age
  • Patients who have an initial HBA score less than or equal to 2%
  • Patients who have a sperm count less than or equal to 10,000 motile sperm per ml.
  • Patients who produce less than 4 Metaphase II oocytes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Huntington Reproductive Center

Laguna Hills, California, 92653, United States

Location

Reproductive Science Center of the Bay Area

San Ramon, California, 94583, United States

Location

Georgia Reproductive Specialists

Atlanta, Georgia, 30342, United States

Location

Reproductive Biology Associates

Atlanta, Georgia, 30342, United States

Location

Fertility Centers of Illinois

Chicago, Illinois, 60610, United States

Location

CNY Fertility Center

Syracuse, New York, 13205, United States

Location

Abington IVF and Genetics Toll Center for Reprodcution

Abington, Pennsylvania, 19001, United States

Location

Center for Reproduction and Infertility, Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02903, United States

Location

Seattle Reproductive Medicine

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Worrilow KC, Eid S, Woodhouse D, Perloe M, Smith S, Witmyer J, Ivani K, Khoury C, Ball GD, Elliot T, Lieberman J. Use of hyaluronan in the selection of sperm for intracytoplasmic sperm injection (ICSI): significant improvement in clinical outcomes--multicenter, double-blinded and randomized controlled trial. Hum Reprod. 2013 Feb;28(2):306-14. doi: 10.1093/humrep/des417. Epub 2012 Nov 30.

    PMID: 23203216DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Kathryn Worrilow, Ph.D.

    Biocoat

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2010

Last Updated

December 28, 2010

Record last verified: 2010-12

Locations

US(9)