Prothrombotic Biomarkers and Ovarian Stimulation (HEMOSTIM)

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

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).

Study Overview

• Status: Completed
• Conditions: Sterility, Female; Reproductive Technology, Assisted
• Intervention / Treatment: Biological: Blood test

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.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • University Hospitals of Geneva
  • Lausanne, Switzerland
    • CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women will be recruited in reproductive unit from 2 hospitals (HUG, Geneva and CHUV, Lausanne) in Switzerland

Description

Inclusion Criteria:

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

Exclusion Criteria:

• >43 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Agonist; Ovarian stimulation with agonist of GnRH	Biological: Blood test; 20 ml of blood, three times
Antagonist; Ovarian stimulation with antagonist of GnRH	Biological: Blood test; 20 ml of blood, three times

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Justine Hugon-Rodin, MD, PHD, Hôpitaux de Paris, Université de Paris; Principal Investigator: Alessandro Casini, MD, Hopitaux Universitaires de Geneve

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: haemostasis; thrombosis; Ovarian stimulation; thrombin generation
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: CCER2019-02134

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No