Randomized Controlled Trial Comparing Slow-freezing to Vi... | NCT00777387

Studies
Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes

NCT00777387

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Terminated

Last Update Posted

Jan 7, 2014Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

slow-freeze
vitrification

Countries

Canada

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Studies emerged that demonstrated the superiority of vitrification

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Oct 20, 2008

First Submission Date that Met QC Criteria

Oct 20, 2008

First Posted Date

Oct 22, 2008Estimated

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

Jan 6, 2014

Last Update Posted Date

Jan 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ellen Greenblatt, Associate Professor, U of T, Samuel Lunenfeld Research Institute, Mount Sinai HospitalPrincipal Investigator

Lead Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Preservation of fertility is limited. Current methods include embryo cryopreservation and while still experimental, ovarian cryopreservation. In single women who are at risk for infertility secondary to cancer or couples who have ethical reasons to avoid embryo cryopreservation, oocyte cryopreservation is an alternative Purpose of study is to compare slow freeze to vitrification of human oocytes. Successful cryopreservation and subsequent thawing programs are characterized by avoiding ice crystal formation.Vitrification, newer alternative to slow freeze method, process by which water is prevented from forming ice.

Our hypothesis is that higher survival rate per oocyte is to be expected in the vitrification group.

Detailed Description

Although several reviews of smaller studies of cryoprotectant methodology exist randomized controlled trials,comparing slow-freeze-rapid-thaw procedure to vitrification of oocytes, are not available. The purpose of this study is to compare these two methods of oocyte cryopreservation in human oocytes.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	slow-freeze	Procedure: slow-freeze
2	Active Comparator	vitrification	Procedure: vitrification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
slow-freeze	Procedure	Slow-freeze-rapid-thaw procedure of oocytes is characterized by prolonged exposure of the cell to cryoprotectants in a low metabolic state at very low temperatures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post-thaw oocyte survival rate		2 years

Secondary Outcomes

Measure	Description	Time Frame
fertilization rate		2 years
cleavage		2 years
embryo development

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

14 or more oocytes at ovum pick up
age < 38
bmi < 30

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen M Greenblatt, MD, FRCS(C)	Mount Sinai Hospital, Canada	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital		Toronto	Ontario	M5G 1Z5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17846105	Background	Gook DA, Edgar DH. Human oocyte cryopreservation. Hum Reprod Update. 2007 Nov-Dec;13(6):591-605. doi: 10.1093/humupd/dmm028. Epub 2007 Sep 10.
16735826	Background	Porcu E, Venturoli S. Progress with oocyte cryopreservation. Curr Opin Obstet Gynecol. 2006 Jun;18(3):273-9. doi: 10.1097/01.gco.0000193015.96275.2d.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D044367	Phase Transition
D055585	Physical Phenomena