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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00823420
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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


Condition Intervention Phase
Infertility
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

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 ]

Estimated Enrollment: 240
Study Start Date: May 2009
Estimated Primary Completion Date: May 2011 (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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823420

Contacts
Contact: Johan Smitz, MD PhD johan.smitz@uzbrussel.be

Locations
Belgium
Centre for Reproductive Medicine Not yet recruiting
Brussels, Belgium
Contact: Johan Smitz, MD PhD       johan.smitz@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

No publications provided

Responsible Party: Professor Johan Smitz, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00823420     History of Changes
Other Study ID Numbers: IWT-JSMDV2008
Study First Received: January 13, 2009
Last Updated: January 13, 2009
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
aneuploidy
in-vitro maturation of oocytes

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

ClinicalTrials.gov processed this record on April 15, 2014