A Comparison Between Home-made Vitrification & Thawing Me... | NCT03660904

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

NCT03660904

Sponsor

Benha University

Status

Completed

Last Update Posted

Sep 7, 2018Actual

Enrollment

74Actual

Phase

Phase 2Phase 3

Conditions

Blastocyst Disintegration

Interventions

home made vitrification & thawing kit
commercially made vitrification & thawing kit

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

Oct 1, 2017Actual

Completion Date

Jun 15, 2018Actual

First Submitted Date

Sep 2, 2018

First Submission Date that Met QC Criteria

Sep 6, 2018

First Posted Date

Sep 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2018

Last Update Posted Date

Sep 7, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home made media	Experimental	home made vitrification & thawing kit	Biological: home made vitrification & thawing kit
Commercial media	Active Comparator	commercially available vitrification & thawing kit	Biological: commercially made vitrification & thawing kit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	Home made media

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

blastocysts of infertile couples

Minimum Age

22 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020964	Embryo Loss

Ancestor Terms

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.