Does LAH May Improve the Pregnancy Outcomes?

Does Laser-assisted Hatching(LAH) May Improve the Pregnancy Outcomes in Human?

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Outcomes
• Intervention / Treatment: Device: Laser-assisted hatching system

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
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Wang; Phone Number: 8613259809290; Email: wangmingbio@snnu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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

Number of Arms

2

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of LAH in ART	Assess the clinical pregnancy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of LAH in ART	Incidence of LAH adverse events was assessed by miscarriage rate and multiple gestation rate.	1 year

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Study Chair: Bo Li, Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2018
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (ACTUAL): January 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: pregnancy outcomes; cryopreservation; zona pellucida; laser-assisted hatching (LAH)
• Other Study ID Numbers: 1215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No