Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

This study has been completed.
Sponsor:
Information provided by:
Shady Grove Fertility Reproductive Science Center
ClinicalTrials.gov Identifier:
NCT00114725
First received: June 16, 2005
Last updated: June 23, 2005
Last verified: June 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 16, 2005
Last Updated: June 23, 2005
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014