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

Study Overview
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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).

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.

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

Conditions
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Blastocyst Disintegration

Intervention / Treatment
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* Biological: home made vitrification & thawing kit
* Biological: commercially made vitrification & thawing kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home made media<br>home made vitrification & thawing kit | Biological: home made vitrification & thawing kit<br>* home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too<br>|
| Active Comparator: Commercial media<br>commercially available vitrification & thawing kit | Biological: commercially made vitrification & thawing kit<br>* commercially available vitrification & thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blastocyst immediate survival | The effect of Vitrification protocol on the blastocyst immediate survival | 0 hour at time of thawing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | clinical pregnancy rate in these cases | 2 weeks after transfer | 
| live birth rate | live birth rate of positive pregnancy cases | 9 months | 
| Blastocyst survival at 6 hours | The effect of Vitrification protocol on the blastocyst survival after 6 hours | 6 hours after thawing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitrification, blastocysts, home-made media