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Intrauterine Embryo Development With ANECOVA Device

This study is currently recruiting participants.
Verified by Instituto Valenciano de Infertilidad, Spain, August 2007

Sponsored by: Instituto Valenciano de Infertilidad, Spain
Information provided by: Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT00480103
  Purpose

We aim to compare the morphological and chromosomal features of human embryos cultured In Vitro versus those developed in a new In Vivo culture system with encapsulation in utero as well as implantation and pregnancy rate.


Condition Intervention Phase
Healthy
Device: in vivo (ANECOVA D-1) or in vitro culture in 25-µl droplets of cleavage medium (Medicult®) under paraffin oil
Phase III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Open Label, Historical Control, Parallel Assignment
Official Title:   Multi-Center Evaluation Program NCVD1H Intrauterine Embryo'S Development Assisted by ANECOVA ACVd1 Device
  Eligibility
Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Women age below 37
  • Hormonal serum levels within normal ranges (FSH, LH, E2, PRL, P4, T4, TSH)
  • Negative serologic screening for HIV, Hep B and C
  • No uterine or ovarian alterations found by ultrasound
  • Normal BMI (19 - 29 kg/m2).

Exclusion Criteria:

  • At least 8 stage MII oocytes are not retrieved
  • Endometriosis or PCO
  • Severe male factor in the partner
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480103

Contacts
Contact: Martin Velasco, ANECOVA     41 223109542     martin@i4progress.com    
Contact: Carlos Simon, MD PhD     34 963050900     csimon@ivi.es    

Locations
Spain
Instituto Valenciano de Infertilidad Spain     Recruiting
      Valencia, Spain, 46015
      Contact: Dr Carlos Simon, MD PhD     34 96 3050900     csimon@ivi.es    
      Contact: Dra Pilar Alama, MD     34 96 3050900     alama@ivi.es    
      Principal Investigator: Dr Carlos Simon, MD PhD            
      Principal Investigator: Dr. Manuel Fernandez, MD            
      Principal Investigator: Dr. Paul DeVroey, MD PhD            

Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain

Investigators
Study Director:     Martin Velasco     Affiliated    
  More Information


Study ID Numbers:   NCVD1H
First Received:   May 28, 2007
Last Updated:   August 1, 2007
ClinicalTrials.gov Identifier:   NCT00480103
Health Authority:   Spain: Ministry of Health and Consumption

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Embryo morphological and chromosomal features  
Implantation and pregnancy rate  

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on October 03, 2008




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