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

September 6, 2018 updated by: Ahmed Saad, Benha University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blastocyst immediate survival
Time Frame: 0 hour at time of thawing
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
Time Frame: 2 weeks after transfer
clinical pregnancy rate in these cases
2 weeks after transfer
live birth rate
Time Frame: 9 months
live birth rate of positive pregnancy cases
9 months
Blastocyst survival at 6 hours
Time Frame: 6 hours after thawing
The effect of Vitrification protocol on the blastocyst survival after 6 hours
6 hours after thawing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

September 2, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hawaa-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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