Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

Sponsor

Shady Grove Fertility Reproductive Science Center (Other)

Overall Status

Completed

CT.gov ID

NCT00114725

Collaborator

(none)

Enrollment

Location

Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Infertility Infertility, Male	Procedure: Laser-assisted intracytoplasmic sperm injection	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

Study Start Date :

Mar 1, 2004

Study Completion Date :

Oct 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of infertility
Scheduled for IVF with ICSI

Exclusion Criteria:

Retrieval of fewer than 6 mature oocytes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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