Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Universitair Ziekenhuis Brussel
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00823420
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
tetrasomy 18p
MedlinePlus related topics:
Infertility
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | May 2011 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823420
Contacts
| Contact: Johan Smitz, MD PhD | johan.smitz@uzbrussel.be |
Locations
| Belgium | |
| Centre for Reproductive Medicine | Not yet recruiting |
| Brussels, Belgium | |
| Contact: Johan Smitz, MD PhD johan.smitz@uzbrussel.be | |
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
More Information
No publications provided
| Responsible Party: | Professor Johan Smitz, Universitair Ziekenhuis Brussel |
| ClinicalTrials.gov Identifier: | NCT00823420 History of Changes |
| Other Study ID Numbers: | IWT-JSMDV2008 |
| Study First Received: | January 13, 2009 |
| Last Updated: | January 13, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Aneuploidy Infertility Chromosome Aberrations Pathologic Processes Genital Diseases, Male Genital Diseases, Female |
Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013