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Egg-Banking and Ovo-donation

I

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase

Completed
Phase 4

Conditions

Egg Banking

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00785993
0703-C-017-AC

Details and patient eligibility

About

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.

Enrollment

320 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

320 participants in 2 patient groups

Control Group
Active Comparator group
Description:
Fresh donor oocytes
Treatment:
Other: Protocolary IVF treatment with fresh donor oocytes
Group I
Experimental group
Description:
vitrified donor oocytes
Treatment:
Other: Vitrification of oocytes for IVF treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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