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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 : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Brief Summary:
A defect in the hatching stage is considered an important cause of implantation failure. Therefore, assisted hatching (AH), which involves artificial disruption of the zona pellucida, has been proposed as a method for improving the capacity of the embryo to implant. 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 aim of this study was to evaluate the effects of laser-assisted hatching(LAH) on clinical outcomes. Patients were randomly divided into control and LAH groups. The zona pellucida was thinned or drilled with a diode laser. Relevant parameters are recorded to evaluate the validity of LAH in ART.

Condition or disease Intervention/treatment Phase
Pregnancy Outcomes Device: Laser-assisted hatching system Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 : May 1, 2019
Estimated Study Completion Date : August 1, 2019

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.
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.



Primary Outcome Measures :
  1. Efficacy of LAH in ART [ Time Frame: 6 months ]
    Assess the clinical pregnancy


Secondary Outcome Measures :
  1. Feasibility of LAH in ART [ Time Frame: 1 year ]
    Incidence of LAH adverse events was assessed by miscarriage rate and multiple gestation rate.



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Ages Eligible for Study:   22 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: wang ming 8613259809290 wangmingbio@snnu.edu.cn

Locations
China, Shaanxi
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: wang ming         
Sponsors and Collaborators
Tang-Du Hospital
Investigators
Study Chair: li bo Tang-Du Hospital

Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT03810157     History of Changes
Other Study ID Numbers: 1215
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tang-Du Hospital:
laser-assisted hatching (LAH)
zona pellucida
cryopreservation
pregnancy outcomes