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(Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) has been replaced by other system)
Information provided by (Responsible Party):
Michel De Vos, Universitair Ziekenhuis Brussel Identifier:
First received: January 13, 2009
Last updated: December 2, 2014
Last verified: December 2014

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
Procedure: prematuration culture
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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.


Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00822874

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

No publications provided

Responsible Party: Michel De Vos, Clinical Professor of Reproductive Medicine, Universitair Ziekenhuis Brussel Identifier: NCT00822874     History of Changes
Other Study ID Numbers: IWT-JSMDV2008pilot
Study First Received: January 13, 2009
Last Updated: December 2, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Universitair Ziekenhuis Brussel:
PCOS and normal ovulatory patients
in-vitro maturation of oocytes

Additional relevant MeSH terms:
Chromosome Aberrations
Pathologic Processes
Phosphodiesterase 3 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors processed this record on October 06, 2015