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Prothrombotic Biomarkers and Ovarian Stimulation

NCT ID: NCT04188444

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Sterility, Female Reproductive Technology, Assisted

Keywords

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Ovarian stimulation thrombin generation haemostasis thrombosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Agonist

Ovarian stimulation with agonist of GnRH

Blood test

Intervention Type BIOLOGICAL

20 ml of blood, three times

Antagonist

Ovarian stimulation with antagonist of GnRH

Blood test

Intervention Type BIOLOGICAL

20 ml of blood, three times

Interventions

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Blood test

20 ml of blood, three times

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \>43 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Casini Alessandro

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justine Hugon-Rodin, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux de Paris, Université de Paris

Alessandro Casini, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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University Hospitals of Geneva

Geneva, , Switzerland

Site Status

CHUV

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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Hugon-Rodin J, Casini A, Benard J, Poncet A, Raverot V, Fontana P, Vulliemoz N, Streuli I. Prothrombotic biomarkers during controlled ovarian stimulation for assisted reproductive technology. Fertil Steril. 2023 Jun;119(6):976-984. doi: 10.1016/j.fertnstert.2023.02.009. Epub 2023 Feb 16.

Reference Type DERIVED
PMID: 36805437 (View on PubMed)

Other Identifiers

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CCER2019-02134

Identifier Type: -

Identifier Source: org_study_id