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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2018-06-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Blastocyst Disintegration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Caregivers Investigators

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

Study Groups

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Home made media

home made vitrification \& thawing kit

Group Type EXPERIMENTAL

home made vitrification & thawing kit

Intervention Type BIOLOGICAL

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

Commercial media

commercially available vitrification \& thawing kit

Group Type ACTIVE_COMPARATOR

commercially made vitrification & thawing kit

Intervention Type BIOLOGICAL

commercially available vitrification \& thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too

Interventions

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home made vitrification & thawing kit

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

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL