NCT00822874

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3.8 years

First QC Date

January 13, 2009

Last Update Submit

December 2, 2014

Conditions

Infertility

Keywords

PCOS and normal ovulatory patientsaneuploidyin-vitro maturation of oocytes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

in-vitro maturation of oocytes

EXPERIMENTAL
Procedure: prematuration culture

Interventions

prematuration culturePROCEDURE

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.

in-vitro maturation of oocytes

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • major uterine or ovarian abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Reproductive Medicine

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

InfertilityPolycystic Ovary SyndromeAneuploidy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System DiseasesChromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Reproductive Medicine

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

BE(1)