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Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential

This study has been terminated.
(Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) has been replaced by other system)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00822874
First Posted: January 15, 2009
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michel De Vos, Universitair Ziekenhuis Brussel
  Purpose
A single centre randomised controlled trial investigating the influence of a novel prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of oocytes - pilot study.

Condition Intervention Phase
Infertility Procedure: prematuration culture Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of a Prematuration Culture With a PDE3-I on Embryonic Aneuploidy Rate and Developmental Potential - a Pilot Study

Further study details as provided by Michel De Vos, Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Incidence of aneuploidy rate by fluorescence in situ hybridisation (FISH) technique in 6 to 8 cell embryos from prolonged (PMC) IVM compared to conventional IVM on sibling oocytes. [ Time Frame: 3 days after egg retrieval ]

Secondary Outcome Measures:
  • Implantation potential of embryos from conventional IVM performed on Type II COC. Efficiency of both maturation systems in obtaining blastocysts. Endometrium quality in IVM cycles. [ Time Frame: 7 days after egg retrieval ]

Enrollment: 115
Study Start Date: January 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: in-vitro maturation of oocytes Procedure: prematuration culture
The aneuploidy rate and the developmental potential of embryos obtained from PDE3 inhibitor-treated oocytes (a "prolonged" IVM (PMC)) in comparison to "conventional" IVM will be analysed. It is intended to assess the nuclear and cytogenetic constitution of the obtained embryos.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers, either with PCOS/PCOS-like ovaries, or with normal ovaries, who undergo oocyte donation for research
  • AFC at least 10
  • AMH: > 5 μg/L
  • Female age < 36 years

Exclusion Criteria:

  • major uterine or ovarian abnormalities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822874


Locations
Belgium
Centre for Reproductive Medicine
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

Responsible Party: Michel De Vos, Clinical Professor of Reproductive Medicine, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00822874     History of Changes
Other Study ID Numbers: IWT-JSMDV2008pilot
First Submitted: January 13, 2009
First Posted: January 15, 2009
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Michel De Vos, Universitair Ziekenhuis Brussel:
PCOS and normal ovulatory patients
aneuploidy
in-vitro maturation of oocytes

Additional relevant MeSH terms:
Infertility
Aneuploidy
Genital Diseases, Male
Genital Diseases, Female
Chromosome Aberrations
Pathologic Processes
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action