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CompletedNCT00785993Updated Oct 2, 2009

Egg-Banking and Ovo-donation

A Phase 4 interventional study of Vitrification of oocytes for IVF treatment and Protocolary IVF treatment with fresh donor oocytes in Egg Banking, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-02.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
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Study 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.

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Conditions studied

  • Egg Banking

Keywords

  • Egg banking, clinical outcome
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In context

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 72 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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.
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Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Active comparator
    Control Group

    Fresh donor oocytes

    Other: Protocolary IVF treatment with fresh donor oocytes

  • Experimental
    Group I

    vitrified donor oocytes

    Other: Vitrification of oocytes for IVF treatment

Interventions

  • OtherVitrification of oocytes for IVF treatment
  • OtherProtocolary IVF treatment with fresh donor oocytes
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What researchers measure

Primary outcomes

  1. To evaluate the clinical outcome in an ovum donation program conducted with egg-banking.

    Time frame: 14 days

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Study locations

1 site
  • Instituto Valenciano de Infertilidad
    Valencia, Valencia 46015, Spain
08

References and documents

Publications

  • 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. PubMed 20591872 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00785993
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
First posted
Nov 5, 2008
Start date
Nov 2008
Primary completion
Sep 2009
Completion
Oct 2009
Last update
Oct 2, 2009

Study contacts

Ana Cobo, PhD
principal investigator · Instituto Valenciano de Infertilidad
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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