Placenta; ImplantationNCT00593775
The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study
A study testing assisted hatching in people with Placenta; Implantation, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 47 yearsHealthy volunteers can take part
- Conditions the study is for
- Placenta; Implantation
- What is being tested?
- assisted hatching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 647 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2006to Jul 2008
- 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 47 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients with frozen 2pn, embryos and blastocysts who want to start an embryo thawing cycle can be included in this study.
Who cannot join
- Patients participating in the embryo reception program are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
In view of insufficient clinical evidence demonstrating the value of AH at the start of our study and in view of the need for higher implantation and LBRs in our ART programme within a series of reimbursed cycles, a prospective randomized controlled trial was performed to evaluate the effect of AH, by modified quarter laser-assisted zona thinning (mQLAZT), in our cryopreservation program. The primary aim was to test the hypothesis that the IR per embryo transferred is higher after transfer of frozen/vitrified-thawed/warmed embryos with thinned ZP after mQLAZT when compared with the transfer of frozen/vitrified-thawed/warmed embryos without mQLAZT.
- Conditions
- Placenta; Implantation
- Being tested
- assisted hatching
- Keywords
- implantation rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assisted hatchingProcedure or surgery
assisted hatching with laser
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | control group without intervention |
| AH group | Active comparator | assisted hatching performed on the embryo Receives: Procedure: assisted hatching |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical implantation rate per embryo transferred
Measured: at 6-8 weeks of pregnancy
Secondary outcomes (1)
pregnancy rate per transfer
Measured: at 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startFeb 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta; ImplantationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Debrock, KU Leuven
- Investigators
- Thomas M D'Hooghe, MD, Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593775
- Sponsor's protocol ID
- ML3497
- Other IDs
- ML3497
- Status last verified
- Apr 2017
- First submitted
- 4 Jan 2008
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21659315
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laser Assisted Hatching in Thawing Cycles: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00593775
- Acronym / sponsor ID
- ML3497
- Conditions
- Placenta; Implantation
- Keywords
- implantation rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Jan 2008 (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.
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).
Detailed description
In view of insufficient clinical evidence demonstrating the value of AH at the start of our study and in view of the need for higher implantation and LBRs in our ART programme within a series of reimbursed cycles, a prospective randomized controlled trial was performed to evaluate the effect of AH, by modified quarter laser-assisted zona thinning (mQLAZT), in our cryopreservation program. The primary aim was to test the hypothesis that the IR per embryo transferred is higher after transfer of frozen/vitrified-thawed/warmed embryos with thinned ZP after mQLAZT when compared with the transfer of frozen/vitrified-thawed/warmed embryos without mQLAZT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –control group without intervention |
| AH group | Active comparator | Procedure: assisted hatchingassisted hatching performed on the embryo |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients with frozen 2pn, embryos and blastocysts who want to start an embryo thawing cycle can be included in this study.
Key exclusion criteria (1 listed)
- Patients participating in the embryo reception program are excluded.
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 |
|---|---|---|
| assisted hatchingassisted hatching with laser | Procedure or surgery | AH group |
Primary outcome
clinical implantation rate per embryo transferred
Time frame: at 6-8 weeks of pregnancy
1 secondary outcome
pregnancy rate per transfer
Time frame: at 14-16 days after ovulation or 17 days after the start of progesterone supplementation in a hormone replacement freeze-thaw cycle
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 2 May 2017.
- Derived from this study: PubMed 21659315Debrock 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.
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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.
Thomas M D'Hooghe, MD study director
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assisted hatching in people with Placenta; Implantation, run by KU Leuven at 1 site in Belgium.
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 1 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 2 May 2017. 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 Belgium. 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?
clinical implantation rate per embryo transferred (time frame: at 6-8 weeks of pregnancy). 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 NCT00593775, which also lists 1 linked publication.
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 2 May 2017.