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Intrauterine Embryo Development With ANECOVA Device

This study has been terminated.
(INHERENT MODIFICATIONS NEEDED BEFORE PROCEEDING)
Sponsor:
Collaborator:
Anecova
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00480103
First received: May 28, 2007
Last updated: March 3, 2011
Last verified: March 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Multi-Center Evaluation Program NCVD1H Intrauterine Embryo'S Development Assisted by ANECOVA ACVd1 Device

Resource links provided by NLM:

Drug Information available for: Paraffin
U.S. FDA Resources

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

Study Start Date: August 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  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

Locations
Spain
Instituto Valenciano de Infertilidad Spain
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Anecova
Investigators
Study Director: Martin Velasco Affiliated
  More Information

No publications provided by Instituto Valenciano de Infertilidad, Spain

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Carlos Simon, Instituto Valenciano de Infertilidad
ClinicalTrials.gov Identifier: NCT00480103     History of Changes
Other Study ID Numbers: NCVD1H
Study First Received: May 28, 2007
Last Updated: March 3, 2011
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

ClinicalTrials.gov processed this record on May 23, 2013