- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00340587
Human Sperm Binding to Transgenic Mouse Eggs
April 4, 2018 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20814
- Suburban Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jurrien Dean, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 2, 1997
Study Completion
February 24, 2016
Study Registration Dates
First Submitted
June 19, 2006
First Submitted That Met QC Criteria
June 19, 2006
First Posted (Estimate)
June 21, 2006
Study Record Updates
Last Update Posted (Actual)
April 5, 2018
Last Update Submitted That Met QC Criteria
April 4, 2018
Last Verified
February 24, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 999997039
- OH97-DK-N039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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