Prothrombotic Biomarkers and Ovarian Stimulation
HEMOSTIM
Thrombotic Profile of Ovarian Stimulation Protocols in Reproductive Medical Assistance: a Prospective Cohort Study
1 other identifier
observational
65
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 27, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedNovember 12, 2020
November 1, 2020
3 years
November 27, 2019
November 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in normalized APC sensitivity ratio
Haemostasis parameters: thrombin Generation Assay
T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Secondary Outcomes (1)
Change in fibrinolysis assay
T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Study Arms (2)
Agonist
Ovarian stimulation with agonist of GnRH
Antagonist
Ovarian stimulation with antagonist of GnRH
Interventions
Eligibility Criteria
Women will be recruited in reproductive unit from 2 hospitals (HUG, Geneva and CHUV, Lausanne) in Switzerland
You may qualify if:
- Women older than 18 years
- Sub-fertile and undergoing IVF
You may not qualify if:
- \>43 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospitals of Geneva
Geneva, Switzerland
CHUV
Lausanne, Switzerland
Related Publications (1)
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.
PMID: 36805437DERIVED
Biospecimen
Serum and plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justine Hugon-Rodin, MD, PHD
Hôpitaux de Paris, Université de Paris
- PRINCIPAL INVESTIGATOR
Alessandro Casini, MD
University Hospital, Geneva
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 27, 2019
First Posted
December 5, 2019
Study Start
March 1, 2017
Primary Completion
March 1, 2020
Study Completion
September 30, 2020
Last Updated
November 12, 2020
Record last verified: 2020-11