- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810157
Does LAH May Improve the Pregnancy Outcomes?
Does Laser-assisted Hatching(LAH) May Improve the Pregnancy Outcomes in Human?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hatching is a very important process for successful implantation involving the breaking of the embryo out of the zona pellucida at the blastocyst stage. Inadequate hatching of the blastocyst might lead to implantation failure in ART. Currently, a variety of AH techniques have been used including zona thinning and the opening or complete removal of the zona by laser. But the advantage of using laser to facilitate the hatching process of embryos in ART practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore, the investigator aim to discuss the effectiveness of LAH in ART.
In this study, patients were randomly divided into control and LAH groups. A quarter of zona pellucida of the cleavage-stage embryo was thinned to 6.6 μm. All operation was performed in the empty region without contact to the blastomere in order to minimize the blastomere damage. The ZP of blastocyst was drilled with laser, the ZP opening 20% of its initial length. The operation was performed in the opposite region of ICM in order to minimize the damage. In the control group, embryos were transplanted without LAH. The rate of clinical pregnancy, live-birth, miscarriage, multiple gestation were evaluated. This research intends to discuss whether LAH can improve the clinical outcomes in ART, and further choice the appropriate LAH action site.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ming Wang
- Phone Number: 8613259809290
- Email: wangmingbio@snnu.edu.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710038
- Recruiting
- Tangdu Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing IVF/ICSI-ET cycle;
- The zone pellucida of the cleavage-stage embryo is thicker than 8 μm.
Exclusion Criteria:
- Number of embryos transferred per cycle >2;
- The transferred embryos including fresh and frozen cycle in the same cycle;
- Embryos developed from the frozen-thawed oocytes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Laser-assisted hatching system
Embryos were exposed to a dose of laser energy focused outside the zona pellucida by aser-assisted hatching system.
|
The ZP was thinned or drilled with the Laser-assisted hatching system.
The laser pulse was 0.296 ms.
Laser aperture was 8μm.
|
NO_INTERVENTION: Control group
Nothing is done.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of LAH in ART
Time Frame: 6 months
|
Assess the clinical pregnancy
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of LAH in ART
Time Frame: 1 year
|
Incidence of LAH adverse events was assessed by miscarriage rate and multiple gestation rate.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Bo Li, Tang-Du Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1215
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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