Prothrombotic Biomarkers and Ovarian Stimulation

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

Sponsors

Lead Sponsor: University Hospital, Geneva

Source University Hospital, Geneva
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.

Overall Status Active, not recruiting
Start Date March 1, 2017
Completion Date June 30, 2020
Primary Completion Date March 1, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Change in normalized APC sensitivity ratio T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Secondary Outcome
Measure Time Frame
Change in fibrinolysis assay T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Enrollment 65
Condition
Intervention

Intervention Type: Biological

Intervention Name: Blood test

Description: 20 ml of blood, three times

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- Women older than 18 years

- Sub-fertile and undergoing IVF

Exclusion Criteria:

- >43 years old

Gender: Female

Minimum Age: 18 Years

Maximum Age: 43 Years

Healthy Volunteers: No

Overall Official
Location
Facility:
University Hospitals of Geneva | Geneva, Switzerland
CHUV | Lausanne, Switzerland
Location Countries

Switzerland

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University Hospital, Geneva

Investigator Full Name: Casini Alessandro

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Agonist

Description: Ovarian stimulation with agonist of GnRH

Label: Antagonist

Description: Ovarian stimulation with antagonist of GnRH

Acronym HEMOSTIM
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov