InfertilityNCT00114725
Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
A study testing Laser-assisted intracytoplasmic sperm injection in people with Infertility and Infertility, Male, run by Shady Grove Fertility Reproductive Science Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility, Infertility, Male
- What is being tested?
- Laser-assisted intracytoplasmic sperm injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Oct 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of infertility
- Scheduled for IVF with ICSI
Who cannot join
- Retrieval of fewer than 6 mature oocytes
Trial locations and contacts
1 site in 1 country.
United States1 site
Shady Grove Fertility Reproductive Science Center
Rockville, Maryland, 20850
About this study
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.
- Conditions
- Infertility, Infertility, Male
- Being tested
- Laser-assisted intracytoplasmic sperm injection
- Keywords
- In Vitro Fertilization, Intracytoplasmic Sperm Injection, Oocytes, Zona Pellucida, Oolemma, Fertilization, Preimplantation Embryo Development
- Medical subject headings
- Infertility, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-assisted intracytoplasmic sperm injectionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2005 (estimated)
- Study startMar 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Shady Grove Fertility Reproductive Science Center
- Sponsor type
- University, hospital or other
- Investigators
- Alana Davis, BS, Principal investigator, Shady Grove Fertility Reproductive Science CenterKevin S Richter, PhD, Study director, Shady Grove Fertility Reproductive Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114725
- Sponsor's protocol ID
- P2004-1
- Status last verified
- Jun 2005
- First submitted
- 16 Jun 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
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.
PubMed 21560622Kurashige 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.
PubMed 21931635Chand 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.
PubMed 22359603Semiglazov 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.
PubMed 22238935Rienzi 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.
PubMed 15196721
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT00114725
- Acronym / sponsor ID
- P2004-1
- Conditions
- Infertility, Infertility, Male
- Keywords
- In Vitro Fertilization, Intracytoplasmic Sperm Injection, Oocytes, Zona Pellucida, Oolemma, Fertilization, Preimplantation Embryo Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Shady Grove Fertility Reproductive Science CenterUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Oct 2004
- First posted
- 17 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of infertility
- Scheduled for IVF with ICSI
Key exclusion criteria (1 listed)
- Retrieval of fewer than 6 mature oocytes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser-assisted intracytoplasmic sperm injection | Procedure or surgery | – |
Primary outcome
oocyte survival rate 1 day after ICSI
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 21560622Mikhailusov 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.
- Background: PubMed 21931635Kurashige 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.
- Background: PubMed 22359603Chand 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.
- Background: PubMed 22238935Semiglazov 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.
- Background: PubMed 15196721Rienzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alana Davis, BS principal investigator
Shady Grove Fertility Reproductive Science Center
Kevin S Richter, PhD study director
Shady Grove Fertility Reproductive Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser-assisted intracytoplasmic sperm injection in people with Infertility and Infertility, Male, run by Shady Grove Fertility Reproductive Science Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oocyte survival rate 1 day after ICSI. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114725, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.