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Completed

NCT Number: NCT04188444

Prothrombotic Biomarkers and Ovarian Stimulation

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).

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals of Geneva, Geneva, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • >43 years old

Treatment and study plan

blood test

Biological

20 ml of blood, three times

Primary outcomes

  1. Change in normalized APC sensitivity ratio

    Time frame: T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation

    Haemostasis parameters: thrombin Generation Assay

Secondary outcomes

  1. Change in fibrinolysis assay

    Time frame: T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation

    haemostasis parameters: turbidimetry assay

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: HEMOSTIM

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2019
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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