Artificial Shrinkage for Human Blastocyst Prior Vitrification

Vitrification Clinical Trial

— AS  

Official title:

Removal of Blastocoel Fluid Before Blastocyst Vitrification by Laser Pulse and Its Effect on Clinical Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02976662
• Other study ID #: 006735
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2016
• Last updated: November 28, 2016
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Dar AlMaraa Center
• Contact: Yasmin Magdi, M.Sc
• Phone: +201282313979
• Email: yas.magdi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification.

Description:

Human blastocyst formation begins about 5 days after injecting a single sperm into an oocyte in ICSI cycle or incubation of them in IVF cycle. Human blastocyst consists of cells forming an outer layer called trophotoderm that will form the placenta in case of successful implantation, an inner cell mass which become the fetus, a fluid-filled blastocoel cavity in the center, and a surrounding zone pellucida from which the embryo hatches to implant in the uterus. Human blastocyst contains a large amount of liquid in the blastocoel, which alters the infiltration of vitrification solution during the vitrification procedures leading to ice crystal formation. Therefore, investigators need to compare blastocyst survival, clinical pregnancy and implantation rates between vitrified untreated expanded blastocysts and vitrified blastocysts with artificially eliminated blastocoels by a laser pulse prior to vitrification

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• BMI of = 32

Exclusion Criteria:

• Non-expanded blastocysts.

• Women who had uterine pathology or abnormality.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitrification

Intervention

Procedure:
• Artificial shrinkage
Artificially eliminated blastocoelic fluid before vitrification procedures.

Locations

Country	Name	City	State
Egypt	Yasmin Magdi	Benha

Sponsors (2)

Lead Sponsor	Collaborator
Dar AlMaraa Center	Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate	number of intrauterine gestational sacs over the total number of embryos transferred	1 month	Yes