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

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ClinicalTrials.gov Identifier: NCT04124809
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Hawaa Fertility Center
Information provided by (Responsible Party):
Ahmed Saad, Benha University

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

Condition or disease Intervention/treatment Phase
Blastocyst Disintegration Device: laser assisted collapse Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: only the investigator knew the procedure provided for each case
Primary Purpose: Basic Science
Official Title: Truth or Dare; Artificial Blastocoel Collapse of Human Blastocysts Before Vitrification
Actual Study Start Date : January 5, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Study group (artificially laser-collapsed blastocysts)
laser was used as an intervention before blastocyst vitrification to assist rapid blastocyst collapse with vitrification
Device: 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

No Intervention: & control group (blastocysts were vitrified, no laser collapse
blastocyst were vitrified without laser assisted collapse



Primary Outcome Measures :
  1. survival rate [ Time Frame: immediately after thawing ]
    survival rate will be assessed immediately after thawing and compared between both groups.

  2. survival rate [ Time Frame: 140 min after thawing ]
    survival rate will be assessed at 140 minutes after thawing and compared between both groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   blastocysts of infertile couples
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04124809


Contacts
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Contact: ahmed S Saad, Ph.D, MD 0121709989 drahmedsaad@live.com
Contact: Sahar A Eissa, Ph. D 01206260974 saharafify@yahoo.com

Locations
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Egypt
Hawaa Fertility Center Recruiting
Banhā, Qalyubiya, Egypt, 13512
Contact: ahmed S Saad, Ph.D, MD    01221709989    drahmedsaad@live.com   
Contact: Sahar A Eissa, Ph. D    01206260974    saharafify@yahoo.com   
Sponsors and Collaborators
Benha University
Hawaa Fertility Center
Investigators
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Principal Investigator: sahar A Eissa, Ph. D HFC

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Responsible Party: Ahmed Saad, Assistant professor of Obstetrics & Gynecology, Benha University
ClinicalTrials.gov Identifier: NCT04124809     History of Changes
Other Study ID Numbers: Hawaa-7
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the main individual characters of the blastocysts and he data after warming
Supporting Materials: Study Protocol
Time Frame: After publication of the study , for 6 months
Access Criteria: saharafify @yahoo.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Saad, Benha University:
blastocyst
Vitrification
artificial collapse
survival rate
Additional relevant MeSH terms:
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Embryo Loss
Shock
Pathologic Processes
Abortion, Spontaneous
Pregnancy Complications
Death