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

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

Sponsors

Lead sponsor: Benha University

Collaborator: Hawaa Fertility Center

Source 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.

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.

Overall Status Recruiting
Start Date January 5, 2019
Completion Date January 20, 2020
Primary Completion Date December 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
survival rate immediately after thawing
survival rate 140 min after thawing
Enrollment 140
Condition
Intervention

Intervention type: Device

Intervention name: laser assisted collapse

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

Arm group label: Study group (artificially laser-collapsed blastocysts)

Eligibility

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

Gender: Female

Gender based: Yes

Gender description: blastocysts of infertile couples

Minimum age: 20 Years

Maximum age: 37 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
sahar A Eissa, Ph. D Principal Investigator HFC
Overall Contact

Last name: ahmed S Saad, Ph.D, MD

Phone: 0121709989

Email: [email protected]

Location
facility status contact contact_backup Hawaa Fertility Center ahmed S Saad, Ph.D, MD 01221709989 [email protected]
Location Countries

Egypt

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Benha University

Investigator full name: Ahmed Saad

Investigator title: Assistant professor of Obstetrics & Gynecology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Study group (artificially laser-collapsed blastocysts)

Arm group type: Experimental

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

Arm group label: & control group (blastocysts were vitrified, no laser collapse

Arm group type: No Intervention

Description: blastocyst were vitrified without laser assisted collapse

Patient Data Yes
Study Design Info

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.

Primary purpose: Basic Science

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Masking description: only the investigator knew the procedure provided for each case

Source: ClinicalTrials.gov