Vascular Cell Activation, Cell-Derived Microparticles and In Vitro Fertilisation, and In Vitro Fertilisation
PREDHSO
Vascular Cell Activation Throughout Ovarian Hyperstimulation for In Vitro Fertilisation: Role of Cell-Derived Microparticles in the Adverse Outcomes
1 other identifier
observational
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2012
Longer than P75 for all trials
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
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2015
CompletedFirst Submitted
Initial submission to the registry
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2017
CompletedFebruary 13, 2017
February 1, 2017
2.8 years
February 1, 2017
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (78)
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
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
Venipuncture for blood sampling and exam with flow cytometry
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
Venipuncture for blood sampling and exam with flow cytometry
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
Venipuncture for blood sampling and exam with flow cytometry
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
Venipuncture for blood sampling and exam with home made device
At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Venipuncture for blood sampling and exam with home made device
At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal
Quantification of Fibrin monomer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
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 D-dimer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
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 E-selectin in the circulating blood
Venipuncture for blood sampling and exam with commercial device
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 soluble CD 146 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
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 Von Willbrand factor in the circulating blood
Venipuncture for blood sampling and exam with commercial device
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 thrombin-antithrombin complex in the circulating blood
Venipuncture for blood sampling and exam with commercial device
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 prothrombin fragment 1+2 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
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 endothelial origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of Microparticles subsets from platelet origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Venipuncture for blood sampling and exam with home made device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Venipuncture for blood sampling and exam with home made device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of Fibrin monomer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of D-dimer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of E-selectin in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of soluble CD 146 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of Von Willbrand factor in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of thrombin-antithrombin complex in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of prothrombin fragment 1+2 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of Microparticles subsets from platelet origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Venipuncture for blood sampling and exam with home made device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Venipuncture for blood sampling and exam with home made device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of Fibrin monomer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of D-dimer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of E-selectin in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of soluble CD 146 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of Von Willbrand factor in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of thrombin-antithrombin complex in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of prothrombin fragment 1+2 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of Microparticles subsets from platelet origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Venipuncture for blood sampling and exam with home made device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Venipuncture for blood sampling and exam with home made device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of Fibrin monomer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of D-dimer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of E-selectin in the circulating blood
Venipuncture for blood sampling and exam with commercial device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of soluble CD 146 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of Von Willbrand factor in the circulating blood
Venipuncture for blood sampling and exam with commercial device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of thrombin-antithrombin complex in the circulating blood
Venipuncture for blood sampling and exam with commercial device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of prothrombin fragment 1+2 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of Microparticles subsets from platelet origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Venipuncture for blood sampling and exam with home made device
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Venipuncture for blood sampling and exam with home made device
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of Fibrin monomer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of D-dimer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of E-selectin in the circulating blood
Venipuncture for blood sampling and exam with commercial device
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of soluble CD 146 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of Von Willbrand factor in the circulating blood
Venipuncture for blood sampling and exam with commercial device
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of thrombin-antithrombin complex in the circulating blood
Venipuncture for blood sampling and exam with commercial device
9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Quantification of Microparticles subsets from platelet origin in the circulating blood
Venipuncture for blood sampling and exam with commercial device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of Microparticles subsets from platelet origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Venipuncture for blood sampling and exam with home made device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Venipuncture for blood sampling and exam with home made device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of Fibrin monomer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of D-dimer in the circulating blood
Venipuncture for blood sampling and exam with commercial device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of E-selectin in the circulating blood
Venipuncture for blood sampling and exam with commercial device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of soluble CD 146 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of Von Willbrand factor in the circulating blood
Venipuncture for blood sampling and exam with commercial device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of thrombin-antithrombin complex in the circulating blood
Venipuncture for blood sampling and exam with commercial device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Quantification of prothrombin fragment 1+2 in the circulating blood
Venipuncture for blood sampling and exam with commercial device
16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Study Arms (1)
Studied group
Women exposed to ovarian hyperstimulation for In Vitro fertilisation
Eligibility Criteria
Infertile volunteers, aged 18 to 35 years, with neither cardiovascular disease nor Lupus erythematosus related disease, scheduled for In Vitro fertilisation, and assessed from their day 3 basal hormonal assessment, at least to the ovarian triggering of their IVF cycle were included.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Poissy-Saint Germain Hospitallead
- Agence de La Biomédecinecollaborator
Biospecimen
After platelet removal, serum samples will be frozen stored before being processed
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 1, 2017
First Posted
February 13, 2017
Study Start
April 1, 2012
Primary Completion
January 2, 2015
Study Completion
February 1, 2017
Last Updated
February 13, 2017
Record last verified: 2017-02