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Intrauterine Embryo Development With ANECOVA Device (ANECOVA)

This study has been terminated.
(INHERENT MODIFICATIONS NEEDED BEFORE PROCEEDING)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480103
First Posted: May 30, 2007
Last Update Posted: March 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Anecova SA
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
  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: None (Open Label)
Primary Purpose: Screening
Official Title: Multi-Center Evaluation Program NCVD1H Intrauterine Embryo'S Development Assisted by ANECOVA ACVd1 Device

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480103


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

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
First Submitted: May 28, 2007
First Posted: May 30, 2007
Last Update Posted: March 4, 2011
Last Verified: March 2011

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