Vascular Cell Activation Throughout Ovarian Hyperstimulation for In Vitro Fertilisation: Role of Cell-Derived Microparticles in the Adverse Outcomes

Poissy-Saint Germain Hospital0 sites50 target enrollmentApril 1, 2012

ConditionsInfertility Hyperstimulation Syndrome, Ovaian Thrombosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility
Sponsor: Poissy-Saint Germain Hospital
Enrollment: 50
Primary Endpoint: Quantification of Microparticles subsets from endothelial origin in the circulating blood
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Introduction: Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic phenomenon, poorly understood and difficult to predict, complicating intense ovarian stimulation cycle. The most severe symptoms, which associate vascular permeability disorders and hypercoagulability, occur in 0.2 to 1% of the cases and often require intensive care.

Activation of endothelial, platelet, erythrocyte or leukocyte cells trigger the release of small specific vesicles, called microparticles, used as markers.

Classically leading to endothelial dysfunction and hypercoagulability, the endothelial activation phenomenon could constitute the main cause of OHSS or help predict its severity, as established for various other diseases (cerebral stroke, infarct and lupus...). However, so far, this endothelial activation role has never been studied.

Objectives:

Evaluate the serum level of microparticles as a predictor of adverse outcomes; correlate it to hypercoagulability and changes of endothelial permeability associated with this syndrome.

Methodology: Prospective Pilote Cohort study, evaluating before and throughout the ovarian stimulation cycle (6 samples/patient), the serum modulation of:

Endothelial activation markers (endothelial-derived microparticles, E-selectin)
Procoagulant markers (microparticles from platelet, erythrocyte or leukocyte origin, Von Willbrand factor, thrombin-antithrombin complex, prothrombin fragment 1+2)
Endothelial disjunction marker (soluble CD 146) A group of 50 patients will be assessed Techniques: Flow cytometry for measurement of microparticles expressing non specific (Annexin V) and cell specific surface determinants (CD 31, CD 41, CD 45 or glycophorin A). Use of commercial kits for other serum markers.

Registry

clinicaltrials.gov

Start Date

April 1, 2012

End Date

February 1, 2017

Last Updated

9 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Poissy-Saint Germain Hospital

Responsible Party

Principal Investigator

Antoine Torre

Medical Doctor

Poissy-Saint Germain Hospital

Eligibility Criteria

Inclusion Criteria

•Between 18 and 35 years old
•With Health Insurance
•Scheduled for their first ovarian stimulation in an IVF or ICSI program in our centre
•Whose blood samples will be collected in our hospital

Exclusion Criteria

•Suffering or having suffered from a disease likely to alter their vascular system and thus modulate their rates of microparticles:
•auto-immune disease (systemic lupus erythematosus26, antiphospholipid syndrome)
•cardiovascular risk factors: cardiovascular disease history, diabetes, arterial hypertension, dyslipidemia
•Tobacco addiction.
•Presenting a blood œstradiol rate \> 5000 pg/ml at ovulation triggering (criterion of stimulation cancellation) and more generally, every patient which ovulation has not been triggered.