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Effect of the Number of Inseminated Spermatozoa on Subsequent Human Embryonic Development in Vitro

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ClinicalTrials.gov Identifier: NCT00710476
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : July 4, 2008
Information provided by:

Study Description
Brief Summary:
In order to reach fertilization in the context of IVF, the presence of high concentrations of spermatozoa is associated with a higher degree of sperm metabolism and a higher concentration of sperm degradation products, which may adversely affect not only sperm and oocyte viability and the fertilization rate. The effect of a high concentration of sperm used for oocyte insemination appears also to be negative on embryo development (Dumoulin et al 1992*). If that is true, lowering the sperm concentration for oocyte insemination might improve embryo quality and result in a higher implantation rate per embryo. Therefore, we tested the hypothesis that the percentage of 8 cell-embryos on day 3 after IVF is significantly higher (40%) after insemination with a low sperm concentration (150 000/ml spermatozoa) than after insemination with a higher sperm concentration (30%; group 600 000/ml spermatozoa).

Condition or disease Intervention/treatment
Spermatozoa and Embryos Procedure: Insemination

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of the Number of Inseminated Spermatozoa on Subsequent Human Embryonic Development in Vitro
Study Start Date : August 2006
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Insemination of the oocytes with a lower concentration of spermatozoa.
Procedure: Insemination
Insemination with a lower concentration of spermatozoa: 150 000 spermatozoa/ml
No Intervention: 2
Insemination with a normal concentration of spermatozoa.

Outcome Measures

Primary Outcome Measures :
  1. embryo quality [ Time Frame: 36 hours ]

Secondary Outcome Measures :
  1. implantation rate [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All patients with at laest 4 oocytes
  • A sperm sample with a total motility count after processing of at least 1000 000 spermatozoa per ml

Exclusion Criteria:

  • All ICSI cycles
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00710476

Sponsors and Collaborators
University Hospital, Gasthuisberg
Principal Investigator: Thomas D'Hooghe, Prof. Dr. University Hospital Leuven, Leuven, Belgium
More Information

Responsible Party: Prof. Dr. T D'Hooghe, University Hospital, Gasthuisberg, Leuven, Belgium
ClinicalTrials.gov Identifier: NCT00710476     History of Changes
Other Study ID Numbers: dwille2
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: July 4, 2008
Last Verified: January 2008