Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

Infertility Clinical Trial

Official title:

Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114725
• Other study ID #: P2004-1
• Status: Completed
• Phase: N/A
• First received: June 16, 2005
• Last updated: June 23, 2005
• Start date: March 2004
• Est. completion date: October 2004

Study information

• Verified date: June 2005
• Source: Shady Grove Fertility Reproductive Science Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Diagnosis of infertility

• Scheduled for IVF with ICSI

Exclusion Criteria:

• Retrieval of fewer than 6 mature oocytes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Procedure:
• Laser-assisted intracytoplasmic sperm injection

Locations

Country	Name	City	State
United States	Shady Grove Fertility Reproductive Science Center	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Shady Grove Fertility Reproductive Science Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Chand AL, Wijayakumara DD, Knower KC, Herridge KA, Howard TL, Lazarus KA, Clyne CD. The orphan nuclear receptor LRH-1 and ERa 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. — View Citation

Kurashige H, Câteau 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oocyte survival rate 1 day after ICSI
Secondary	normal fertilization rate 1 day after ICSI
Secondary	embryo cell numbers 2 and 3 days after ICSI
Secondary	embryo fragmentation rates 2 and 3 days after ICSI
Secondary	embryo compaction rate through day 7 after ICSI
Secondary	blastocyst formation rate through day 7 after ICSI