The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study
1 other identifier
interventional
647
1 country
1
Brief Summary
The successful hatching process is a prerequisite for implantation. Freezing/thawing cycles can impair the hatching process by introducing changes in the composition of the zona pellucida. The purpose of this study is to test the hypothesis that the implantation rate per embryo and the clinical pregnancy rate per embryo transfer is higher after embryo transfer of frozen-thawed embryos with opened or thinned ZP after assisted hatching when compared to embryo transfer of frozen-thawed embryos without assisted hatching. All patients starting a thawing cycle (with frozen embryos on d1-d2-d3-d5) can be included in this RTC study. Assisted hatching will be performed with a non-contact 1.48 diode laser system (MTG, Germany).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedMay 2, 2017
April 1, 2017
2.4 years
January 4, 2008
April 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical implantation rate per embryo transferred
at 6-8 weeks of pregnancy
Secondary Outcomes (1)
pregnancy rate per transfer
at 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle
Study Arms (2)
control
NO INTERVENTIONcontrol group without intervention
AH group
ACTIVE COMPARATORassisted hatching performed on the embryo
Interventions
Eligibility Criteria
You may qualify if:
- All patients with frozen 2pn, embryos and blastocysts who want to start an embryo thawing cycle can be included in this study.
You may not qualify if:
- Patients participating in the embryo reception program are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
Leuven University Fertility Center
Leuven, 3000, Belgium
Related Publications (1)
Debrock S, Peeraer K, Spiessens C, Willemen D, De Loecker P, D'Hooghe TM. The effect of modified quarter laser-assisted zona thinning on the implantation rate per embryo in frozen/vitrified-thawed/warmed embryo transfer cycles: a prospective randomized controlled trial. Hum Reprod. 2011 Aug;26(8):1997-2007. doi: 10.1093/humrep/der161. Epub 2011 Jun 8.
PMID: 21659315DERIVED
Study Officials
- STUDY DIRECTOR
Thomas M D'Hooghe, MD
UZ Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, clinical embryologist
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 15, 2008
Study Start
February 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
May 2, 2017
Record last verified: 2017-04