Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI

IVF Clinical Trial

Official title:

Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561249
• Other study ID #: 2007/453
• Status: Completed
• Phase: N/A
• First received: November 16, 2007
• Last updated: January 24, 2014
• Start date: December 2007
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

At the time of transfer of frozen/thawed embryos in human IVF/ICSI, patients are randomized between study and control group.In the control group no additional intervention takes place on the embryos to be transferred,in the study group, embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old and above

• Female

Exclusion Criteria:

• No exclusion criteria, except not possible to give informed consent

Study Design

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

Related Conditions & MeSH terms

• ICSI
• IVF

Intervention

Procedure:
• laser assisted hatching
Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical implantation per transferred embryo		fourteen days after transfer	Yes
Secondary	clinical pregnancy and birth per transfer		resp. 12 weeks and 38 weeks after transfer	Yes

External Links

•   Website University Hospital Ghent