Egg-Banking and Ovo-donation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Egg Banking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control Group

Fresh donor oocytes

Group Type ACTIVE_COMPARATOR

Protocolary IVF treatment with fresh donor oocytes

Intervention Type OTHER

Group I

vitrified donor oocytes

Group Type EXPERIMENTAL

Vitrification of oocytes for IVF treatment

Intervention Type OTHER

Interventions

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Vitrification of oocytes for IVF treatment

Intervention Type OTHER

Protocolary IVF treatment with fresh donor oocytes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Receptors

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

Donors:

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes