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Influence 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
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
January 13, 2009
Last Updated
December 4, 2014
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
University of Adelaide, Cook Group Incorporated
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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The Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) has been replaced by a different formulation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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