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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00340587
Other study ID # 999997039
Secondary ID OH97-DK-N039
Status Completed
Phase
First received June 19, 2006
Last updated April 4, 2018
Start date May 2, 1997
Est. completion date February 24, 2016

Study information

Verified date February 24, 2016
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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 plasma membrane and enters the egg s cytoplasm. The zona pellucida, an extracellular matrix composed of three or four glycoproteins, 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 plasma membrane. We have established transgenic mouse lines that express one or more human or rat 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. Alternatively, anonymous fertile human sperm will be obtained from a commercial sperm bank using a donor consent agreement. Only procedures already being performed on subjects for diagnostic or treatment purposes will be used.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date February 24, 2016
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - INCLUSION CRITERIA:

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Suburban Hospital Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Rankin T, Dean J. The molecular genetics of the zona pellucida: mouse mutations and infertility. Mol Hum Reprod. 1996 Nov;2(11):889-94. Review. — View Citation

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. — View Citation

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