Clinical trial NCT00114725: Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
Official title: Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Infertility, Male
Keywords: In Vitro Fertilization
Intracytoplasmic Sperm Injection
Oocytes
Zona Pellucida
Oolemma
Fertilization
Preimplantation Embryo Development
Lead sponsor: Shady Grove Fertility Reproductive Science Center
Sponsor class: OTHER
First posted: 2005-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of infertility
* Scheduled for IVF with ICSI

Exclusion Criteria:

* Retrieval of fewer than 6 mature oocytes

Primary outcomes:
measure: oocyte survival rate 1 day after ICSI
Secondary outcomes:
measure: normal fertilization rate 1 day after ICSI
measure: embryo cell numbers 2 and 3 days after ICSI
measure: embryo fragmentation rates 2 and 3 days after ICSI
measure: embryo compaction rate through day 7 after ICSI
measure: blastocyst formation rate through day 7 after ICSI
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Shady Grove Fertility Reproductive Science Center
state: Maryland
Study officials:
affiliation: Shady Grove Fertility Reproductive Science Center
name: Alana Davis, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Shady Grove Fertility Reproductive Science Center
name: Kevin S Richter, PhD
role: STUDY_DIRECTOR
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