Prothrombotic Biomarkers and Ovarian Stimulation

Completed

• Conditions: Sterility, Female; Reproductive Technology, Assisted
• Interventions: Biological: Blood test

• Registration Number: NCT04188444
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Primary Completion: 2020-03-01
• Study Completion: 2020-09-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

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

Exclusion Criteria

• >43 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antagonist	Blood test	Ovarian stimulation with antagonist of GnRH
Agonist	Blood test	Ovarian stimulation with agonist of GnRH

Primary Outcome Measures

Name	Time	Method
Change in normalized APC sensitivity ratio	T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation	Haemostasis parameters: thrombin Generation Assay

Secondary Outcome Measures

Name	Time	Method
Change in fibrinolysis assay	T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation	haemostasis parameters: turbidimetry assay

Trial Locations

Locations (2)

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland

CHUV; 🇨🇭 Lausanne, Switzerland