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
NCT00822874
Collaborator
(none)
115
1
1
45
2.6
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 - pilot study.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
115 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 - a Pilot Study
Study Start Date
:
Jan 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.
|
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 | 1090 |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Michel De Vos,
Clinical Professor of Reproductive Medicine,
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00822874
Other Study ID Numbers:
- IWT-JSMDV2008pilot
First Posted:
Jan 15, 2009
Last Update Posted:
Dec 3, 2014
Last Verified:
Dec 1, 2014
Keywords provided by Michel De Vos,
Clinical Professor of Reproductive Medicine,
Universitair Ziekenhuis Brussel
Additional relevant MeSH terms: