Skip to main content
OpenTrials
Completed

NCT Number: NCT03051230

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Blood Coagulation Disorders Cardiovascular Diseases Embolism and Thrombosis Genital Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hyperstimulation Syndrome, Ovaian Thrombosis Urogenital Diseases Vascular Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

  63. 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

  64. 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

  65. 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

  66. 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

  67. 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

  68. 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

  69. 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

  70. 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

  71. 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

  72. 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

  73. 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

  74. 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

  75. 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

  76. 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

  77. 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

  78. 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

Sponsors and collaborators

Lead sponsor

Poissy-Saint Germain Hospital

Other

Collaborators

  • Agence de La Biomédecine

Registry information

Official study title

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

Acronym: PREDHSO

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Feb 13, 2017
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.