NCT03810157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 26, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

January 14, 2019

Last Update Submit

June 24, 2019

Conditions

Pregnancy Outcomes

Keywords

laser-assisted hatching (LAH)zona pellucidacryopreservationpregnancy outcomes

Outcome Measures

Primary Outcomes (1)

  • Efficacy of LAH in ART

    Assess the clinical pregnancy

    6 months

Secondary Outcomes (1)

  • Feasibility of LAH in ART

    1 year

Study Arms (2)

Laser-assisted hatching system

EXPERIMENTAL

Embryos were exposed to a dose of laser energy focused outside the zona pellucida by aser-assisted hatching system.

Device: Laser-assisted hatching system

Control group

NO INTERVENTION

Nothing is done.

Interventions

Laser-assisted hatching systemDEVICE

The ZP was thinned or drilled with the Laser-assisted hatching system. The laser pulse was 0.296 ms. Laser aperture was 8μm.

Laser-assisted hatching system

Eligibility Criteria

Age22 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF/ICSI-ET cycle；
  • The zone pellucida of the cleavage-stage embryo is thicker than 8 μm.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Study Officials

  • Bo Li

    Tang-Du Hospital

    STUDY CHAIR

Central Study Contacts

Ming Wang

CONTACT

8613259809290wangmingbio@snnu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 18, 2019

Study Start

December 26, 2018

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations

CN(1)