Intrauterine Embryo Development With ANECOVA Device

NCT ID: NCT00480103

Last Updated: 2011-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anecova SA

INDUSTRY

Sponsor Role collaborator

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Instituto Valenciano de Infertilidad

Principal Investigators

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Martin Velasco

Role: STUDY_DIRECTOR

Affiliated

Locations

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Instituto Valenciano de Infertilidad Spain

Valencia, , Spain

Site Status

Countries

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Spain

References

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Blockeel C, Mock P, Verheyen G, Bouche N, Le Goff P, Heyman Y, Wrenzycki C, Hoffmann K, Niemann H, Haentjens P, de Los Santos MJ, Fernandez-Sanchez M, Velasco M, Aebischer P, Devroey P, Simon C. An in vivo culture system for human embryos using an encapsulation technology: a pilot study. Hum Reprod. 2009 Apr;24(4):790-6. doi: 10.1093/humrep/dep005. Epub 2009 Mar 9.

Reference Type DERIVED
PMID: 19273881 (View on PubMed)

Other Identifiers

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NCVD1H

Identifier Type: -

Identifier Source: org_study_id

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