Back to resultsInfluence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential
Primary Purpose
Infertility
Status
Terminated
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
prematuration culture
Sponsored by
About this trial
This is an interventional basic science trial for Infertility focused on measuring PCOS and normal ovulatory patients, aneuploidy, in-vitro maturation of oocytes
Eligibility 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
Sites / Locations
- Centre for Reproductive Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
in-vitro maturation of oocytes
Arm Description
Outcomes
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.
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.
Full Information
NCT ID
NCT00823420
First Posted
January 13, 2009
Last Updated
December 4, 2014
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
University of Adelaide, Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00823420
Brief Title
Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential
Official Title
Influence of a Prematuration Culture With a PDE3-I on Embryonic Aneuploidy Rate and Developmental Potential
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
The Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) has been replaced by a different formulation
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
University of Adelaide, Cook Group Incorporated
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
PCOS and normal ovulatory patients, aneuploidy, in-vitro maturation of oocytes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
in-vitro maturation of oocytes
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
prematuration culture
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Centre for Reproductive Medicine
City
Brussels
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential
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