NCT00480103

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2007

Typical duration for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 4, 2011

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

May 28, 2007

Last Update Submit

March 3, 2011

Conditions

Healthy

Keywords

Embryo morphological and chromosomal featuresImplantation and pregnancy rate

Interventions

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

Eligibility Criteria

Age18 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • At least 8 stage MII oocytes are not retrieved
  • Endometriosis or PCO
  • Severe male factor in the partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de Infertilidad Spain

Valencia, 46015, Spain

Location

Related Publications (1)

  • 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.

    PMID: 19273881DERIVED

Study Officials

  • Martin Velasco

    Affiliated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2007

First Posted

May 30, 2007

Study Start

August 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 4, 2011

Record last verified: 2011-03

Locations

ES(1)