Truth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage

NCT ID: NCT04124809

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-05

Study Completion Date

2021-10-01

Brief Summary

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: This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.

Detailed Description

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One arm study of 60 patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.

Conditions

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Blastocyst Disintegration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
only the investigator knew the procedure provided for each case

Study Groups

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Study group (artificially laser-collapsed blastocysts)

laser was used as an intervention before blastocyst vitrification to assist rapid blastocyst collapse with vitrification

Group Type EXPERIMENTAL

laser assisted collapse

Intervention Type DEVICE

Apply 1-2 pulses of laser using the Saturn between 2 adjacent trophectoderm cells away from the inner cell mass in the blastocysts

& control group (blastocysts were vitrified, no laser collapse

blastocyst were vitrified without laser assisted collapse

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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laser assisted collapse

Apply 1-2 pulses of laser using the Saturn between 2 adjacent trophectoderm cells away from the inner cell mass in the blastocysts

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4

Exclusion Criteria

* bad quality blastocysts expansion rate less than 3
Minimum Eligible Age

20 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hawaa Fertility Center

OTHER

Sponsor Role collaborator

Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Saad

Assistant professor of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sahar A Eissa, Ph. D

Role: PRINCIPAL_INVESTIGATOR

HFC

Locations

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Hawaa Fertility Center

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Hawaa-7

Identifier Type: -

Identifier Source: org_study_id

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