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

Infertility Clinical Trial

Official title:

Influence of a Prematuration Culture With a PDE3-I on Embryonic Aneuploidy Rate and Developmental Potential - a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00822874
• Other study ID #: IWT-JSMDV2008pilot
• Status: Terminated
• Phase: Phase 1
• First received: January 13, 2009
• Last updated: December 2, 2014
• Start date: January 2009
• Est. completion date: October 2012

Study information

• Verified date: December 2014
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aneuploidy
• Infertility

Intervention

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.

Locations

Country	Name	City	State
Belgium	Centre for Reproductive Medicine	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes