Egg-Banking and Ovo-donation

Phase 4

Completed

• Conditions: Egg Banking
• Interventions: Other: Vitrification of oocytes for IVF treatment; Other: Protocolary IVF treatment with fresh donor oocytes

• Registration Number: NCT00785993
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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 available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2009-09
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Vitrification of oocytes for IVF treatment	vitrified donor oocytes
Control Group	Protocolary IVF treatment with fresh donor oocytes	Fresh donor oocytes

Primary Outcome Measures

Name	Time	Method
To evaluate the clinical outcome in an ovum donation program conducted with egg-banking.	14 days

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidad; 🇪🇸 Valencia, Spain