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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Terminated

CT.gov ID

NCT00823420

Collaborator

University of Adelaide (Other), Cook Group Incorporated (Industry)

213

Enrollment

Location

Arm

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: prematuration culture	Phase 1

Study Design

Study Type:

Interventional

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 1, 2009

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

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. [3 days after egg retrieval]

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. [7 days after egg retrieval]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Centre for Reproductive Medicine	Brussels		Belgium

Sponsors and Collaborators

Universitair Ziekenhuis Brussel
University of Adelaide
Cook Group Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT00823420

Other Study ID Numbers:

IWT-JSMDV2008

First Posted:

Jan 15, 2009

Last Update Posted:

Dec 5, 2014

Last Verified:

Jan 1, 2009

Keywords provided by Universitair Ziekenhuis Brussel

PCOS and normal ovulatory patients

aneuploidy

in-vitro maturation of oocytes

Additional relevant MeSH terms:

Infertility

Aneuploidy

Study Results

No Results Posted as of Dec 5, 2014