Sterility, FemaleHEMOSTIMNCT04188444
Prothrombotic Biomarkers and Ovarian Stimulation
An observational study of Sterility, Female and Reproductive Technology, Assisted, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Sterility, Female, Reproductive Technology, Assisted
- What is being tested?
- Blood test
- How many people
- 65 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Mar 2017to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Women will be recruited in reproductive unit from 2 hospitals (HUG, Geneva and CHUV, Lausanne) in Switzerland
Who may be able to join
- Women older than 18 years
- Sub-fertile and undergoing IVF
Who cannot join
- >43 years old
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Thrombotic Profile of Ovarian Stimulation Protocols in Reproductive Medical Assistance: a Prospective Cohort Study
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).
Read the 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.
- Being tested
- Blood test
- Keywords
- Ovarian stimulation, thrombin generation, haemostasis, thrombosis
- Medical subject headings
- Infertility, Female, Helping Behavior, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
20 ml of blood, three times
| Study group | Role | What they receive |
|---|---|---|
| Agonist | Ovarian stimulation with agonist of GnRH Receives: Biological: Blood test | |
| Antagonist | Ovarian stimulation with antagonist of GnRH Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in normalized APC sensitivity ratio
Haemostasis parameters: thrombin Generation Assay
Measured: T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Secondary outcomes (1)
Change in fibrinolysis assay
haemostasis parameters: turbidimetry assay
Measured: T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Mar 2017
- Primary completion1 Mar 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sterility, FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casini Alessandro, University Hospital, Geneva
- Investigators
- Justine Hugon-Rodin, MD, PHD, Principal investigator, Hôpitaux de Paris, Université de ParisAlessandro Casini, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188444
- Sponsor's protocol ID
- CCER2019-02134
- Acronym
- HEMOSTIM
- Status last verified
- Nov 2020
- First submitted
- 27 Nov 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36805437
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombotic Profile of Ovarian Stimulation Protocols in Reproductive Medical Assistance: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04188444
- Acronym / sponsor ID
- HEMOSTIM / CCER2019-02134
- Keywords
- Ovarian stimulation, thrombin generation, haemostasis, thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agonist | – | Biological: Blood testOvarian stimulation with agonist of GnRH |
| Antagonist | – | Biological: Blood testOvarian stimulation with antagonist of GnRH |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women will be recruited in reproductive unit from 2 hospitals (HUG, Geneva and CHUV, Lausanne) in Switzerland
Key inclusion criteria (2 listed)
- Women older than 18 years
- Sub-fertile and undergoing IVF
Key exclusion criteria (1 listed)
- >43 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test20 ml of blood, three times | Biological | Agonist, Antagonist |
Primary outcome
Change in normalized APC sensitivity ratio
Time frame: T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Haemostasis parameters: thrombin Generation Assay
1 secondary outcome
Change in fibrinolysis assay
Time frame: T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 36805437Hugon-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justine Hugon-Rodin, MD, PHD principal investigator
Hôpitaux de Paris, Université de Paris
Alessandro Casini, MD principal investigator
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sterility, Female and Reproductive Technology, Assisted, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in normalized APC sensitivity ratio (time frame: T1: inclusion; T2: day1 ovarian stimulation; T3: day7 after ovarian stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.