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

Phase 2

Completed

• Conditions: Blastocyst Disintegration
• Interventions: Biological: home made vitrification & thawing kit; Biological: commercially made vitrification & thawing kit

• Registration Number: NCT03660904
• Lead Sponsor: Benha University

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2017-10-01
• Study Completion: 2018-06-15
• Status Verified: 2018-09
• Study First Submitted: 2018-09-02
• Study First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Study First Posted: 2018-09-07
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home made media	home made vitrification & thawing kit	home made vitrification \& thawing kit
Commercial media	commercially made vitrification & thawing kit	commercially available vitrification \& thawing kit

Primary Outcome Measures

Name	Time	Method
blastocyst immediate survival	0 hour at time of thawing	The effect of Vitrification protocol on the blastocyst immediate survival

Secondary Outcome Measures

Name	Time	Method
live birth rate	9 months	live birth rate of positive pregnancy cases
Blastocyst survival at 6 hours	6 hours after thawing	The effect of Vitrification protocol on the blastocyst survival after 6 hours
pregnancy rate	2 weeks after transfer	clinical pregnancy rate in these cases