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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03660904

Enrollment

Registered

2018-09-07

Start date

2015-10-01

Completion date

2018-06-15

Last updated

2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blastocyst Disintegration

Keywords

vitrification, blastocysts, home-made media

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.

Interventions

BIOLOGICALhome made vitrification & thawing kit

home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too

BIOLOGICALcommercially 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Caregiver, Investigator)

Masking description

only the investigator knew the procedure and the media provided for each case

Intervention model description

Group 1 blastocysts were vitrified with the Vit (home made) HM according to shady grove protocol using open system on cryotop vit. device and thawed with gradual thawing technique using HM thawing media according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kit using open system on cryotop vit. device and thawed using Global fast thaw kit. Blastocysts were assessed immediately for survival, 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.

Eligibility

Sex/Gender

FEMALE

Age

22 Years to 37 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
blastocyst immediate survival	0 hour at time of thawing	The effect of Vitrification protocol on the blastocyst immediate survival

Secondary

Measure	Time frame	Description
pregnancy rate	2 weeks after transfer	clinical pregnancy rate in these cases
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026