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

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ClinicalTrials.gov Identifier: NCT00823420
Recruitment Status : Terminated (The Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) has been replaced by a different formulation)
First Posted : January 15, 2009
Last Update Posted : December 5, 2014
Sponsor:
Collaborators:
University of Adelaide
Cook Group Incorporated
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Procedure: prematuration culture Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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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

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): NCT00823420


Locations
Belgium
Centre for Reproductive Medicine
Brussels, Belgium
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
University of Adelaide
Cook Group Incorporated

Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00823420     History of Changes
Other Study ID Numbers: IWT-JSMDV2008
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: January 2009

Keywords provided by 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