Closed Vitrification of Oocytes | NCT01745536

Studies
Closed Vitrification of Oocytes

NCT01745536

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Withdrawn

Last Update Posted

Mar 8, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Oocytes are vitrified/stored using a closed device
Oocytes are vitrified/stored using an open device

Countries

Spain

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

ID	Type	Description	Link
Clinical Trials.gov	Registry Identifier	Clinical Trials.gov

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

NO RECRUITMENT

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Nov 29, 2012

First Submission Date that Met QC Criteria

Dec 7, 2012

First Posted Date

Dec 10, 2012Estimated

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

Mar 7, 2016

Last Update Posted Date

Mar 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ana Cobo, Cryo-biology Unit director at IVI Valencia, Spain, Instituto Valenciano de Infertilidad, IVI VALENCIAPrincipal Investigator

Lead Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIAOTHER

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

This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.

Detailed Description

The Cryotop method for oocyte vitrification is classified as "open system", which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitrified oocytes using closed Cryotop®	Experimental	Oocytes are vitrified/stored using a closed device	Procedure: Oocytes are vitrified/stored using a closed device
Vitrified oocytes using open Cryotop®	Active Comparator	Oocytes are vitrified/stored using an open device	Procedure: Oocytes are vitrified/stored using an open device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oocytes are vitrified/stored using a closed device	Procedure	Vitrification will be carried out using a modification of the current device (Cryotop®), thus providing air tight sealing. Closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival after oocyte vitrification using the closed device Cryotop®	Survival will be evaluated morphologically two hours after warming.	>2 hours

Secondary Outcomes

Measure	Description	Time Frame
Embryo development		From thawing and until pregnancy outcome (0-9 months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Donors:

< 35 years old
Normal physical and gynecological examinations
No family history of hereditary or chromosomal diseases.
Normal karyotype
Negative screening for sexually transmitted diseases.

Oocyte recipients:

Oocyte recipients < 50 years old
Body mass index < 30
< 2 previous IVF failures
No severe male factor
No recurrent miscarriage
No hidrosalpinx
No myoma
No adenomyosis
No AMH alterations

Exclusion Criteria:

Donors and recipients not meeting inclusion criteria

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana Cobo, PhD	IVI Valencia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ivi Valencia		Valencia	Valencia	46015	Spain
IVI Valencia

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

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