- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114725
Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
June 23, 2005 updated by: Shady Grove Fertility Reproductive Science Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
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Rockville, Maryland, United States, 20850
- Shady Grove Fertility Reproductive Science Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of infertility
- Scheduled for IVF with ICSI
Exclusion Criteria:
- Retrieval of fewer than 6 mature oocytes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
oocyte survival rate 1 day after ICSI
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
normal fertilization rate 1 day after ICSI
|
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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
|
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blastocyst formation rate through day 7 after ICSI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alana Davis, BS, Shady Grove Fertility Reproductive Science Center
- Study Director: Kevin S Richter, PhD, Shady Grove Fertility Reproductive Science Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Completion
October 1, 2004
Study Registration Dates
First Submitted
June 16, 2005
First Submitted That Met QC Criteria
June 16, 2005
First Posted (Estimate)
June 17, 2005
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
June 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2004-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.