IVFNCT00561249
Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI
A study testing laser assisted hatching in people with IVF and ICSI, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- laser assisted hatching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2007to Apr 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above
- Female
Who cannot join
- No exclusion criteria, except not possible to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- laser assisted hatching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser assisted hatchingProcedure or surgery
Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo. Receives: Procedure: laser assisted hatching |
| 2 | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical implantation per transferred embryo
Measured: fourteen days after transfer
Secondary outcomes (1)
clinical pregnancy and birth per transfer
Measured: resp. 12 weeks and 38 weeks after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra De Sutter, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561249
- Sponsor's protocol ID
- 2007/453
- Status last verified
- Jan 2014
- First submitted
- 16 Nov 2007
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI
- ClinicalTrials.gov ID
- NCT00561249
- Acronym / sponsor ID
- 2007/453
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Nov 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: laser assisted hatchingEmbryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo. |
| 2 | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old and above
- Female
Key exclusion criteria (1 listed)
- No exclusion criteria, except not possible to give informed consent
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 hatchingEmbryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo | Procedure or surgery | 1 |
Primary outcome
clinical implantation per transferred embryo
Time frame: fourteen days after transfer
1 secondary outcome
clinical pregnancy and birth per transfer
Time frame: resp. 12 weeks and 38 weeks after transfer
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 27 Jan 2014.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Petra De Sutter, MD, PhD principal investigator
University Hospital, Ghent
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 hatching in people with IVF and ICSI, run by University Hospital, Ghent 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 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 27 Jan 2014. 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 per transferred embryo (time frame: fourteen days after transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2014.