Prothrombotic Biomarkers and Ovarian Stimulation

Study Overview
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Brief Summary
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The aim of this study is to assess the impact of different protocols used for ovarian stimulation during in vitro fertilization procedures (IVF) on prothrombotic biomarkers (blood coagulation markers associated with thromboembolic events) in the units of reproductive medicine in two university hospitals (HUG, Geneva and CHUV, Lausanne).

Detailed Description
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HEMO-STIM is a prospective multicentric cohort study of subfertile women undergoing ART. It is an epidemiologic observational study. All women older than 18 years attending the reproductive medicine unit (UMREG, Geneva, HUG or UMR, Lausanne, CHUV) and undergoing an IVF have been and will be recruited consecutively and included. The type of stimulation protocol used is recorded. All measurements (specific haemostasis test with a thrombin generation assay before and after adjunction of APC) that are part of the study will be performed in the HUG laboratories in order to limit inter-dosage variability. The 1st blood test will be performed at inclusion in the absence of any hormonal treatment (T1). A 2nd blood test will be performed on the day of ovulation triggering (T2). A 3rd blood test will be performed 7 days after ovulation triggering (T3). The comparison of different protocols has never been performed and data on the effect of antagonist protocols for IVF on haemostasis are lacking. The measurement of intermediate biomarkers of thromboembolic risk during different IVF stimulation protocols (agonists and antagonists) would allow the comparison of their thrombotic profile and to optimize the risk/benefit ratio during ART by prescribing protocols at lower vascular risk, in particular in women identified as being at risk for thromboembolic events.

Official Title
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Thrombotic Profile of Ovarian Stimulation Protocols in Reproductive Medical Assistance: a Prospective Cohort Study

Conditions
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Sterility, Female, Reproductive Technology, Assisted

Intervention / Treatment
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* Biological: Blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women older than 18 years Sub-fertile and undergoing IVF Exclusion Criteria: >43 years old

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Agonist<br>Ovarian stimulation with agonist of GnRH | Biological: Blood test<br>* 20 ml of blood, three times<br>|
| Antagonist<br>Ovarian stimulation with antagonist of GnRH | Biological: Blood test<br>* 20 ml of blood, three times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in normalized APC sensitivity ratio | Haemostasis parameters: thrombin Generation Assay | T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fibrinolysis assay | haemostasis parameters: turbidimetry assay | T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian stimulation, thrombin generation, haemostasis, thrombosis