Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Instituto Valenciano de Infertilidad, Spain.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00977821
First received: September 15, 2009
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

For an efficient "egg banking" system, an equally efficient cryopreservation strategy that ensures the viability of the oocytes is required. Very recently, improved and new methods are yielding satisfactory results. In particular, vitrification is providing excellent results for both survival and clinical outcomes. However, to evaluate the over all out come there are other parameters to be considered. In this sense, capacity development of embryos generated after oocyte vitrification is a major factor when assessing the viability of vitrified oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the blastocyst stage will be highly valuable to fully assess the effectiveness of the "egg banking" and its contribution to ovum donation programs.

The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted with vitrified versus fresh oocytes.


Condition Intervention Phase
Infertility
Other: IVF
Other: Oocyte Vitrification
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 760
Study Start Date: September 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fresh
Embryo transfer with fresh oocytes
Other: IVF
Experimental: Frozen
Embryo transfer with vitrified oocytes
Other: Oocyte Vitrification

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-35 year old
  • Normal response (8-15 follicles) to long protocol of ovarian stimulation with hCG
  • Donors with normal menstrual cycles (21-35 day duration)
  • Donors with BMI between 18-25 Kg/m2

Exclusion Criteria:

  • Donors with two or more previous miscarriages
  • Polycystic ovary syndrome
  • Donors with antecedents of poor embrionary quality not attributed to masculine factor
  • Donors with drop of estradiol of more than 10% or estradiol plateau.
  • Donors with a high response>20 oocytes and or levels above 3000pg/ml of estradiol the day of the administration of chorionic gonadotrophin (hCG)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977821

Contacts
Contact: Carlos Simon, MD PhD 963050900 csimon@ivi.es
Contact: Ana Cobo, PhD 963050900 acobo@ivi.es

Locations
Spain
IVI Valencia Recruiting
Valencia, Spain, 46015
Contact: Leslie Atkinson, MA    963050900    latkinson@ivi.es   
Principal Investigator: Carlos Simon, MD PhD         
Sub-Investigator: Ana Cobo, PhD         
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided

Responsible Party: Dr. Carlos Simon, Fundación IVI
ClinicalTrials.gov Identifier: NCT00977821     History of Changes
Other Study ID Numbers: 0901-F-054-CS
Study First Received: September 15, 2009
Last Updated: March 30, 2012
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014