Back to resultsLaser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
Primary Purpose
Infertility, Infertility, Male
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser-assisted intracytoplasmic sperm injection
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring In Vitro Fertilization, Intracytoplasmic Sperm Injection, Oocytes, Zona Pellucida, Oolemma, Fertilization, Preimplantation Embryo Development
Eligibility Criteria
Inclusion Criteria: Diagnosis of infertility Scheduled for IVF with ICSI Exclusion Criteria: Retrieval of fewer than 6 mature oocytes
Sites / Locations
- Shady Grove Fertility Reproductive Science Center
Outcomes
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
Full Information
NCT ID
NCT00114725
First Posted
June 16, 2005
Last Updated
June 23, 2005
Sponsor
Shady Grove Fertility Reproductive Science Center
1. Study Identification
Unique Protocol Identification Number
NCT00114725
Brief Title
Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
Official Title
Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shady Grove Fertility Reproductive Science Center
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Infertility, Male
Keywords
In Vitro Fertilization, Intracytoplasmic Sperm Injection, Oocytes, Zona Pellucida, Oolemma, Fertilization, Preimplantation Embryo Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Laser-assisted intracytoplasmic sperm injection
Primary Outcome Measure Information:
Title
oocyte survival rate 1 day after ICSI
Secondary Outcome Measure Information:
Title
normal fertilization rate 1 day after ICSI
Title
embryo cell numbers 2 and 3 days after ICSI
Title
embryo fragmentation rates 2 and 3 days after ICSI
Title
embryo compaction rate through day 7 after ICSI
Title
blastocyst formation rate through day 7 after ICSI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of infertility
Scheduled for IVF with ICSI
Exclusion Criteria:
Retrieval of fewer than 6 mature oocytes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana Davis, BS
Organizational Affiliation
Shady Grove Fertility Reproductive Science Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin S Richter, PhD
Organizational Affiliation
Shady Grove Fertility Reproductive Science Center
Official's Role
Study Director
Facility Information:
Facility Name
Shady Grove Fertility Reproductive Science Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21560622
Citation
Mikhailusov SV, Bart BIa, Siluianov SV, Mikhailusova MP, Nikolaeva AS. [Duodenogastric reflux and gastric pathology in the elderly patients]. Eksp Klin Gastroenterol. 2010;(12):54-9. Russian.
Results Reference
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PubMed Identifier
21931635
Citation
Kurashige H, Cateau H. Dendritic slow dynamics enables localized cortical activity to switch between mobile and immobile modes with noisy background input. PLoS One. 2011;6(9):e24007. doi: 10.1371/journal.pone.0024007. Epub 2011 Sep 8.
Results Reference
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PubMed Identifier
22359603
Citation
Chand AL, Wijayakumara DD, Knower KC, Herridge KA, Howard TL, Lazarus KA, Clyne CD. The orphan nuclear receptor LRH-1 and ERalpha activate GREB1 expression to induce breast cancer cell proliferation. PLoS One. 2012;7(2):e31593. doi: 10.1371/journal.pone.0031593. Epub 2012 Feb 16.
Results Reference
background
PubMed Identifier
22238935
Citation
Semiglazov VF, Paltuev RM, Remizov AS, Semiglazov VV, Dashian GA, Bessonov AA, Pen'kov KD, Vasil'ev AG, Semiglazova TIu, Kolar'kova VV. [The role of nanotechnology in creating novel antitumor agents]. Vopr Onkol. 2011;57(5):636-40. Russian.
Results Reference
background
PubMed Identifier
15196721
Citation
Rienzi L, Ubaldi F, Martinez F, Minasi MG, Iacobelli M, Ferrero S, Tesarik J, Greco E. Clinical application of laser-assisted ICSI: a pilot study. Eur J Obstet Gynecol Reprod Biol. 2004 Jul 1;115 Suppl 1:S77-9. doi: 10.1016/j.ejogrb.2004.01.017.
Results Reference
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Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
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