Intrauterine Embryo Development With ANECOVA Device

This study is currently recruiting participants.

Verified by Instituto Valenciano de Infertilidad, Spain, November 2008

Sponsors and Collaborators:	Instituto Valenciano de Infertilidad, Spain Anecova
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

Drug Information available for: Paraffin

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

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

Study Start Date:	August 2007
Estimated Primary Completion Date:	August 2009 (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

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

Anecova

Investigators

Study Director:

Martin Velasco

Affiliated

More Information

Responsible Party:	Instituto Valenciano de Infertilidad ( Dr Carlos Simon )
Study ID Numbers:	NCVD1H
Study First Received:	May 28, 2007
Last Updated:	November 10, 2008
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 January 13, 2009