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

Blastocyst Disintegration Clinical Trial

Official title:

Truth or Dare; Artificial Blastocoel Collapse of Human Blastocysts Before Vitrification

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04124809
• Other study ID #: Hawaa-7
• Status: Terminated
• Phase: N/A
• Start date: January 5, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 1, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Blastocyst Disintegration
• Embryo Loss
• Shock

Intervention

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

Locations

Country	Name	City	State
Egypt	Hawaa Fertility Center	Banha	Qalyubiya

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate	survival rate will be assessed immediately after thawing and compared between both groups.	immediately after thawing
Primary	survival rate	survival rate will be assessed at 140 minutes after thawing and compared between both groups.	140 min after thawing