InfertilityPREDHSONCT03051230
Vascular Cell Activation, Cell-Derived Microparticles and In Vitro Fertilisation, and In Vitro Fertilisation
An observational study of Infertility and Hyperstimulation Syndrome, Ovaian, run by Poissy-Saint Germain Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility, Hyperstimulation Syndrome, Ovaian, Thrombosis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2012to 1 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Vascular Cell Activation Throughout Ovarian Hyperstimulation for In Vitro Fertilisation: Role of Cell-Derived Microparticles in the Adverse Outcomes
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.
Read more
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.
- Conditions
- Infertility, Hyperstimulation Syndrome, Ovaian, Thrombosis
- Keywords
- Blood Coagulation Disorders, Cell-Derived Microparticles, Superovulation, Fertilization in Vitro, Biomarkers
- Medical subject headings
- Infertility, Thrombosis, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Studied group | Women exposed to ovarian hyperstimulation for In Vitro fertilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Venipuncture for blood sampling and exam with flow cytometry
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Apr 2012
- Primary completion2 Jan 2015
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine
- Responsible party
- Principal investigator, Antoine Torre, Poissy-Saint Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051230
- Sponsor's protocol ID
- PREDHSO
- Acronym
- PREDHSO
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Cell Activation Throughout Ovarian Hyperstimulation for In Vitro Fertilisation: Role of Cell-Derived Microparticles in the Adverse Outcomes
- ClinicalTrials.gov ID
- NCT03051230
- Acronym / sponsor ID
- PREDHSO / PREDHSO
- Conditions
- Infertility, Hyperstimulation Syndrome, Ovaian, Thrombosis
- Keywords
- Blood Coagulation Disorders, Cell-Derived Microparticles, Superovulation, Fertilization in Vitro, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 2 Jan 2015 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Studied group | – | –Women exposed to ovarian hyperstimulation for In Vitro fertilisation |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Suffering or having suffered from a disease likely to alter their vascular system and thus modulate their rates of microparticles:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from platelet origin in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal
Venipuncture for blood sampling and exam with home made device
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal
Venipuncture for blood sampling and exam with home made device
Quantification of Fibrin monomer in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with commercial device
Quantification of D-dimer in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with commercial device
Quantification of E-selectin in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with commercial device
Quantification of soluble CD 146 in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with commercial device
Quantification of Von Willbrand factor in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with commercial device
Quantification of thrombin-antithrombin complex in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with commercial device
Quantification of prothrombin fragment 1+2 in the circulating blood
Time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up
Venipuncture for blood sampling and exam with commercial device
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from platelet origin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with home made device
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with home made device
Quantification of Fibrin monomer in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with commercial device
Quantification of D-dimer in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with commercial device
Quantification of E-selectin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with commercial device
Quantification of soluble CD 146 in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with commercial device
Quantification of Von Willbrand factor in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with commercial device
Quantification of thrombin-antithrombin complex in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with commercial device
Quantification of prothrombin fragment 1+2 in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at first day of FSH stimulation
Venipuncture for blood sampling and exam with commercial device
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from platelet origin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with home made device
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with home made device
Quantification of Fibrin monomer in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with commercial device
Quantification of D-dimer in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with commercial device
Quantification of E-selectin in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with commercial device
Quantification of soluble CD 146 in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with commercial device
Quantification of Von Willbrand factor in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with commercial device
Quantification of thrombin-antithrombin complex in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with commercial device
Quantification of prothrombin fragment 1+2 in the circulating blood
Time frame: During ovarian stimulation for IVF (first cycle), at ovarian triggering day, i.e.when ≥ 3 ovarian follicles rich 17mm
Venipuncture for blood sampling and exam with commercial device
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from platelet origin in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with home made device
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with home made device
Quantification of Fibrin monomer in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with commercial device
Quantification of D-dimer in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with commercial device
Quantification of E-selectin in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with commercial device
Quantification of soluble CD 146 in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with commercial device
Quantification of Von Willbrand factor in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with commercial device
Quantification of thrombin-antithrombin complex in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with commercial device
Quantification of prothrombin fragment 1+2 in the circulating blood
Time frame: 4 days after ovarian triggering for IVF (first cycle), at the day of embryo transfer of the Day 2 embryos
Venipuncture for blood sampling and exam with commercial device
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from platelet origin in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with home made device
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with home made device
Quantification of Fibrin monomer in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with commercial device
Quantification of D-dimer in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with commercial device
Quantification of E-selectin in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with commercial device
Quantification of soluble CD 146 in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with commercial device
Quantification of Von Willbrand factor in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with commercial device
Quantification of thrombin-antithrombin complex in the circulating blood
Time frame: 9 days after ovarian triggering for IVF (first cycle), at mid-luteal phase
Venipuncture for blood sampling and exam with commercial device
Quantification of Microparticles subsets from platelet origin in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with commercial device
Quantification of Microparticles subsets from endothelial origin in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from erythrocyte origin in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from leukocyte origin in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Microparticles subsets from platelet origin in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with flow cytometry
Quantification of Tissue Factor-Dependent Procoagulant Activity (MP-TF) in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with home made device
Quantification of Plasmin Generation Capacity (MP-PGC) in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with home made device
Quantification of Fibrin monomer in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with commercial device
Quantification of D-dimer in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with commercial device
Quantification of E-selectin in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with commercial device
Quantification of soluble CD 146 in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with commercial device
Quantification of Von Willbrand factor in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with commercial device
Quantification of thrombin-antithrombin complex in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with commercial device
Quantification of prothrombin fragment 1+2 in the circulating blood
Time frame: 16 days after ovarian triggering for IVF (first cycle), at the day of pregnancy test
Venipuncture for blood sampling and exam with commercial device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Hyperstimulation Syndrome, Ovaian, run by Poissy-Saint Germain Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Microparticles subsets from endothelial origin in the circulating blood (time frame: At day 3 of an unstimulated (i.e. natural) menstrual cycle, before IVF cycle, when basal hormonal assessments is performed for fertility work-up). The study lists 78 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.