Egg-Banking and Ovo-donation | NCT00785993

Studies
Egg-Banking and Ovo-donation

NCT00785993

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Completed

Last Update Posted

Oct 2, 2009Estimated

Enrollment

320Estimated

Phase

Phase 4

Conditions

Egg Banking

Interventions

Vitrification of oocytes for IVF treatment
Protocolary IVF treatment with fresh donor oocytes

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

Status Module

Record Verification Date

Oct 2009

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

Nov 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 4, 2008

First Posted Date

Nov 5, 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

Oct 1, 2009

Last Update Posted Date

Oct 2, 2009Estimated

Description Module

Brief Summary

Egg-banking would considerably simplify the logistics and means by which oocytes could be donated. These banks would make it easier to immediately provide oocytes that would be compatible to the recipient, shortening or even eliminating the problem of long waiting lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically diminishing the risk of transmission of infectious diseases in a fashion analogous to semen banks. The most essential prerequisite for a successful egg cryo-banking program is to have an efficient oocyte cryopreservation technology. Recent studies, including our own experience, have indicated that vitrified oocytes preserve intact their potential to fertilize and further develop into competent embryos, giving high clinical results as well as high survival rates. The aim of this study is to evaluate impact of the establishment of an egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes. Recipients are allocated randomly into each group ("fresh vs. vitrified cycles"). Main outcome measures include survival, fertilization, embryo development and clinical outcome.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	Active Comparator	Fresh donor oocytes	Other: Protocolary IVF treatment with fresh donor oocytes
Group I	Experimental	vitrified donor oocytes	Other: Vitrification of oocytes for IVF treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitrification of oocytes for IVF treatment	Other		Group I
Protocolary IVF treatment with fresh donor oocytes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the clinical outcome in an ovum donation program conducted with egg-banking.		14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Receptors
- Women receiving donor oocytes and whose partners without seere pathology of semen.
- BMI < 25

Donors:

Inclusion Criteria:

18 - 35 years oldaños.

Normal Response (8-15 follicles)to long protocol of ovarian stimulation with hCG
Donors with normal menstrual cycles ( 21-35 day duration).
Donors with Body Mass Index (BMI) between 18-25 Kg/m2

Exclusion Criteria:

Donors with +/= two previous miscarriages'
Polycystic Ovary Syndrome
Donors with antecedents of poor embrionary quality not attributed to masculine factor.
Donors with decline of Estradiol Hormone of more than 10% or Estradiol Hormone plateau.
Donors with a high response >20 ovocitos and/or levels above 3000pg/mL of Estradiol the day of the administration of Chorionic gonadotropin (hCG.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 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	Instituto Valenciano de Infertilidad	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Valenciano de Infertilidad		Valencia	Valencia	46015	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20591872	Derived	Cobo A, Meseguer M, Remohi J, Pellicer A. Use of cryo-banked oocytes in an ovum donation programme: a prospective, randomized, controlled, clinical trial. Hum Reprod. 2010 Sep;25(9):2239-46. doi: 10.1093/humrep/deq146. Epub 2010 Jun 30.