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Prothrombotic Biomarkers and Ovarian Stimulation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04188444
Acronym
HEMOSTIM
Enrollment
65
Registered
2019-12-05
Start date
2017-03-01
Completion date
2020-09-30
Last updated
2020-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproductive Technology, Assisted, Sterility, Female

Keywords

Ovarian stimulation, thrombin generation, haemostasis, thrombosis

Brief 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).

Detailed 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.

Interventions

BIOLOGICALBlood test

20 ml of blood, three times

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

Inclusion criteria

* Women older than 18 years * Sub-fertile and undergoing IVF

Exclusion criteria

* \>43 years old

Design outcomes

Primary

MeasureTime frameDescription
Change in normalized APC sensitivity ratioT1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulationHaemostasis parameters: thrombin Generation Assay

Secondary

MeasureTime frameDescription
Change in fibrinolysis assayT1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulationhaemostasis parameters: turbidimetry assay

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026