NCT00340587

Brief Summary

At fertilization, the binding of sperm to the zona pellucida induces the acrosome reaction releasing lytic enzymes that facilitate the passage of the sperm through the zona. The sperm then fuses with the egg's plasm membrane and enters the egg's cytoplasm. The zona pellucida, an extracellular matrix composed of three glycoproteins (ZP1, ZP2, ZP3), mediates the species-specific binding of sperm to egg. Although homologous proteins are present in mouse and humans, human sperm will not bind to the mouse zona pellucida and when the zona pellucida is experimentally removed, human sperm will not bind or fuse to the mouse egg's plasm membrane. We have created transgenic mouse lines that express one or more human zona proteins. We wish to determine if human sperm will bind to these chimeric zonae and if this binding will induce the human sperm acrosome reaction. Sperm and devitalized eggs will be collected by collaborating institution(s) under protocols and consent forms approved by that institution's IRB. Only procedures already being performed on subjects for diagnostic or treatment purposes will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 1997

Longer than P75 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

May 2, 1997

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
9.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2016

Completed
Last Updated

April 5, 2018

Status Verified

February 24, 2016

First QC Date

June 19, 2006

Last Update Submit

April 4, 2018

Conditions

Fertilization

Keywords

Zona PellucidaHuman EggsZP1, ZP2, ZP3Fertilization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Without regard to ethnic/race background, all subjects will be men and women over the age of 18 who are neither mentally retarded nor disabled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Related Publications (3)

  • Rankin T, Dean J. The molecular genetics of the zona pellucida: mouse mutations and infertility. Mol Hum Reprod. 1996 Nov;2(11):889-94. doi: 10.1093/molehr/2.11.889.

    PMID: 9237231BACKGROUND

  • Rankin T, Familari M, Lee E, Ginsberg A, Dwyer N, Blanchette-Mackie J, Drago J, Westphal H, Dean J. Mice homozygous for an insertional mutation in the Zp3 gene lack a zona pellucida and are infertile. Development. 1996 Sep;122(9):2903-10. doi: 10.1242/dev.122.9.2903.

    PMID: 8787763BACKGROUND

  • Epifano O, Liang LF, Familari M, Moos MC Jr, Dean J. Coordinate expression of the three zona pellucida genes during mouse oogenesis. Development. 1995 Jul;121(7):1947-56. doi: 10.1242/dev.121.7.1947.

    PMID: 7635043BACKGROUND

Study Officials

  • Jurrien Dean, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

May 2, 1997

Study Completion

February 24, 2016

Last Updated

April 5, 2018

Record last verified: 2016-02-24

Locations

US(1)