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

NCT03660904 — Phase 2 / Phase 3, Completed, 74 participants, Benha University

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

Registry	NCT03660904
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: double, basic science
Enrollment	74 (Actual)
Sponsor	Benha University (Other)
Conditions	Blastocyst Disintegration
Interventions	home made vitrification & thawing kit, commercially made vitrification & thawing kit (Biological)
Dates	start 2015-10-01, primary completion 2017-10-01, completion 2018-06-15, first posted 2018-09-07, last updated 2018-09-07

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Home made media	Experimental	Biological: home made vitrification & thawing kit	home made vitrification \& thawing kit
Commercial media	Active comparator	Biological: commercially made vitrification & thawing kit	commercially available vitrification \& thawing kit

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

+Outcome measures

Primary outcomes

blastocyst immediate survival [0 hour at time of thawing]: The effect of Vitrification protocol on the blastocyst immediate survival

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 22 Years to 37 Years

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