Effects of Male-specific Antibodies on Sex Ratio

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02267252
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : January 11, 2018
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital

Brief Summary:
Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa as a possible explanation of the lower sex ratio observed after microinsemination using epididymal sperm from vasectomized men.

Condition or disease Intervention/treatment
Sperm Antibodies Sex Ratio Other: Antibody-sperm binding

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Actual Study Start Date : September 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Y/X sperm ratio after exposure to sperm-specific antibodies [ Time Frame: Up to 28 months ]

Biospecimen Retention:   Samples With DNA
Blood and ejaculates

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Vasectomized men

Inclusion Criteria:

  • Vasectomized men

Exclusion Criteria:

  • Men who do not understand the study information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02267252

Contact: Jens Fedder, MD, PhD +45 26820368

Fertility Clinic, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Jens Fedder, Professor    +45 268 20 368   
Principal Investigator: Jens Fedder, Professor         
Sponsors and Collaborators
Odense University Hospital

Responsible Party: Jens Fedder, Professor, Consultant, Ph.D., Odense University Hospital Identifier: NCT02267252     History of Changes
Other Study ID Numbers: Lab.Reprod.Biol.- Odense.01
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs