NCT00114725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2005

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2005

First QC Date

June 16, 2005

Last Update Submit

June 23, 2005

Conditions

InfertilityInfertility, Male

Keywords

In Vitro FertilizationIntracytoplasmic Sperm InjectionOocytesZona PellucidaOolemmaFertilizationPreimplantation Embryo Development

Outcome Measures

Primary Outcomes (1)

  • oocyte survival rate 1 day after ICSI

Secondary Outcomes (5)

  • 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

Interventions

Laser-assisted intracytoplasmic sperm injectionPROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of infertility
  • Scheduled for IVF with ICSI

You may not qualify if:

  • Retrieval of fewer than 6 mature oocytes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shady Grove Fertility Reproductive Science Center

Rockville, Maryland, 20850, United States

Location

Related Publications (5)

  • 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.

    PMID: 21560622BACKGROUND

  • 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.

    PMID: 21931635BACKGROUND

  • 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.

    PMID: 22359603BACKGROUND

  • 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.

    PMID: 22238935BACKGROUND

  • 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.

    PMID: 15196721BACKGROUND

MeSH Terms

Conditions

InfertilityInfertility, Male

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Study Officials

  • Alana Davis, BS

    Shady Grove Fertility Reproductive Science Center

    PRINCIPAL INVESTIGATOR

  • Kevin S Richter, PhD

    Shady Grove Fertility Reproductive Science Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2005

First Posted

June 17, 2005

Study Start

March 1, 2004

Study Completion

October 1, 2004

Last Updated

June 24, 2005

Record last verified: 2005-06

Locations

US(1)