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Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114725
First Posted: June 17, 2005
Last Update Posted: December 9, 2005
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. Read our disclaimer for details.
Information provided by:
Shady Grove Fertility Reproductive Science Center
  Purpose
Laser-assisted intracytoplasmic sperm injection (ICSI) has been suggested as a more effective alterative to conventional ICSI when this method of insemination is indicated for patients undergoing in vitro fertilization (IVF). Laser-assisted ICSI differs from conventional ICSI in that a laser is used to drill a small hole through the hard outer coating surrounding an egg before the injection needle containing a single sperm is inserted into the egg. The hole eliminates compression of the egg that normally occurs with conventional ICSI, and thus may reduce the chance of damage. Laser-assisted ICSI is hypothesized to result in increased egg survival, and perhaps improved embryo quality, compared to conventional ICSI.

Condition Intervention
Infertility Infertility, Male Procedure: Laser-assisted intracytoplasmic sperm injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

Resource links provided by NLM:


Further study details as provided by Shady Grove Fertility Reproductive Science Center:

Primary Outcome Measures:
  • oocyte survival rate 1 day after ICSI

Secondary Outcome Measures:
  • normal fertilization rate 1 day after ICSI
  • embryo cell numbers 2 and 3 days after ICSI
  • embryo fragmentation rates 2 and 3 days after ICSI
  • embryo compaction rate through day 7 after ICSI
  • blastocyst formation rate through day 7 after ICSI

Estimated Enrollment: 60
Study Start Date: March 2004
Estimated Study Completion Date: October 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of infertility
  • Scheduled for IVF with ICSI

Exclusion Criteria:

  • Retrieval of fewer than 6 mature oocytes
  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): NCT00114725


Locations
United States, Maryland
Shady Grove Fertility Reproductive Science Center
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Shady Grove Fertility Reproductive Science Center
Investigators
Principal Investigator: Alana Davis, BS Shady Grove Fertility Reproductive Science Center
Study Director: Kevin S Richter, PhD Shady Grove Fertility Reproductive Science Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00114725     History of Changes
Other Study ID Numbers: P2004-1
First Submitted: June 16, 2005
First Posted: June 17, 2005
Last Update Posted: December 9, 2005
Last Verified: June 2005

Keywords provided by Shady Grove Fertility Reproductive Science Center:
In Vitro Fertilization
Intracytoplasmic Sperm Injection
Oocytes
Zona Pellucida
Oolemma
Fertilization
Preimplantation Embryo Development

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female