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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00710476
First received: January 4, 2008
Last updated: July 2, 2008
Last verified: January 2008
  Purpose

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 Intervention
Spermatozoa and Embryos
Procedure: Insemination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of the Number of Inseminated Spermatozoa on Subsequent Human Embryonic Development in Vitro

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • embryo quality [ Time Frame: 36 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • implantation rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: August 2006
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00710476

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

No publications provided

Responsible Party: Prof. Dr. T D'Hooghe, University Hospital, Gasthuisberg, Leuven, Belgium
ClinicalTrials.gov Identifier: NCT00710476     History of Changes
Other Study ID Numbers: dwille2
Study First Received: January 4, 2008
Last Updated: July 2, 2008
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

ClinicalTrials.gov processed this record on October 23, 2014