Does LAH May Improve the Pregnancy Outcomes?
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|ClinicalTrials.gov Identifier: NCT03810157|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Outcomes||Device: Laser-assisted hatching system||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Does Laser-assisted Hatching(LAH) May Improve the Pregnancy Outcomes in Human?|
|Actual Study Start Date :||December 26, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Experimental: Laser-assisted hatching system
Embryos were exposed to a dose of laser energy focused outside the zona pellucida by aser-assisted hatching system.
Device: Laser-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.
- Efficacy of LAH in ART [ Time Frame: 6 months ]Assess the clinical pregnancy
- Feasibility of LAH in ART [ Time Frame: 1 year ]Incidence of LAH adverse events was assessed by miscarriage rate and multiple gestation rate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810157
|Contact: Ming Wangfirstname.lastname@example.org|
|Xi'an, Shaanxi, China, 710038|
|Contact: Ming Wang|
|Study Chair:||Bo Li||Tang-Du Hospital|