CompletedNot Applicable

Vascular Cell Activation, Cell-Derived Microparticles and In Vitro Fertilisation, and In Vitro Fertilisation

50 participantsStarted 2012-04-01

Plain-language 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.

Who can participate

Age range

18 Years – 43 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quantification of Microparticles subsets from endothelial origin in the circulating blood

Timeframe: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up

Quantification of Microparticles subsets from erythrocyte origin in the circulating blood

Timeframe: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up

Quantification of Microparticles subsets from leukocyte origin in the circulating blood

Timeframe: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal

Quantification of Microparticles subsets from platelet origin in the circulating blood

Timeframe: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up

Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood

Timeframe: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal

Trial details

NCT IDNCT03051230

SponsorPoissy-Saint Germain Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-01-02

View on ClinicalTrials.gov More Infertility trials