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NCT00480103 Clinical Trial

Intrauterine Embryo Development With ANECOVA Device

Healthy Clinical Trial

— ANECOVA  

Official title:
Multi-Center Evaluation Program NCVD1H Intrauterine Embryo'S Development Assisted by ANECOVA ACVd1 Device

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00480103
Other study ID # NCVD1H
Secondary ID
Status Terminated
Phase Phase 3
First received May 28, 2007
Last updated March 3, 2011
Start date August 2007
Est. completion date November 2008

Study information
Verified date March 2011
Source Instituto Valenciano de Infertilidad, IVI VALENCIA
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health and Consumption
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 36 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Spain Instituto Valenciano de Infertilidad Spain Valencia

Sponsors (2)
Lead Sponsor Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA Anecova SA

Country where clinical trial is conducted

Spain, 

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