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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04188444
Other study ID # CCER2019-02134
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date September 30, 2020

Study information

Verified date November 2020
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date September 30, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 43 Years
Eligibility Inclusion Criteria: - Women older than 18 years - Sub-fertile and undergoing IVF Exclusion Criteria: - >43 years old

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood test
20 ml of blood, three times

Locations

Country Name City State
Switzerland University Hospitals of Geneva Geneva
Switzerland CHUV Lausanne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in normalized APC sensitivity ratio Haemostasis parameters: thrombin Generation Assay T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Secondary Change in fibrinolysis assay haemostasis parameters: turbidimetry assay T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
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