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

This study has been terminated.
(The Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) has been replaced by a different formulation)
Sponsor:
Collaborators:
University of Adelaide
Cook
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00823420
First received: January 13, 2009
Last updated: December 4, 2014
Last verified: January 2009
  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

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: 213
Study Start Date: May 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823420

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

No publications provided

Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00823420     History of Changes
Other Study ID Numbers: IWT-JSMDV2008
Study First Received: January 13, 2009
Last Updated: December 4, 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
aneuploidy
in-vitro maturation of oocytes

ClinicalTrials.gov processed this record on March 26, 2015