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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, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT00480103
First received: May 28, 2007
Last updated: March 3, 2011
Last verified: March 2011
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, IVI VALENCIA
Anecova
Investigators
Study Director: Martin Velasco Affiliated
  More Information

No publications provided by Instituto Valenciano de Infertilidad, IVI VALENCIA

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, IVI VALENCIA:
Embryo morphological and chromosomal features
Implantation and pregnancy rate

ClinicalTrials.gov processed this record on November 27, 2014