A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst

Blastocyst Disintegration Clinical Trial

Official title:

A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst Survival, Expansion and Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660904
• Other study ID #: Hawaa-3
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 1, 2015
• Est. completion date: June 15, 2018

Study information

• Verified date: September 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).

Description:

Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 15, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 37 Years

Eligibility

Inclusion Criteria:

• age of the patients 22-37

• All vitrified & thawed blastocyst.

• unexplained cases or ovarian factors for infertility.

Exclusion Criteria:

• extremes of age

• cases of uterine factor

• endometriosis

Related Conditions & MeSH terms

• Blastocyst Disintegration
• Embryo Loss

Intervention

Biological:
• home made vitrification & thawing kit
home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too
• commercially made vitrification & thawing kit
commercially available vitrification & thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blastocyst immediate survival	The effect of Vitrification protocol on the blastocyst immediate survival	0 hour at time of thawing
Secondary	pregnancy rate	clinical pregnancy rate in these cases	2 weeks after transfer
Secondary	live birth rate	live birth rate of positive pregnancy cases	9 months
Secondary	Blastocyst survival at 6 hours	The effect of Vitrification protocol on the blastocyst survival after 6 hours	6 hours after thawing