Fibrin Blood ClotNCT04166825
Ovarian Hyperstimulation and Fibrin Clot Properties.
A study testing fibrin clot properties in people with Fibrin Blood Clot and Infertility, Female, run by Jagiellonian University at 1 site in Poland.
Trial summary
The impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women. Comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fibrin Blood Clot, Infertility, Female, Endometriosis
- What is being tested?
- fibrin clot properties
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 18 Nov 2019to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertility defined based on the WHO 2010 criteria
Who cannot join
- ovarian involvement
- oral contraceptives use within previous 3 months
- dienogest therapy within 3 months until ART
- thrombotic events in the medical history
- severe hypertension
- diabetes mellitus
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- the presence of known VTE risk factors, including obesity, recent major surgery with prolonged immobilization or trauma,
- deficiency of antithrombin, protein C or protein S,
- antiphospholipid syndrome,
- known malignancy,
- any chronic inflammatory diseases (e.g. rheumatoid arthritis)
- advanced chronic renal disease (estimated glomerular filtration rate [eGFR] <30 ml/min),
- international normalized ratio (INR) more than 1.2 at the day of blood draw
- pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Gynecological Endocrinology Jagiellonian University Medical College
Krakow, Małopolska, 30-501
Magdalena Piróg, MD, PhD, 604514915, magda.m.pulka@gmail.com
Olga Kacalska - Janssen, MD, PhD
About this study
Official title: The Impact of Different Ovarian Hyperstimulation Protocols on Coagulation and Fibrinolysis.
The impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women.
Comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility.
Read the detailed description
Infertility is a common problem. Assisted reproductive techniques (ART) increases the chance of getting pregnant by couples undergoing such treatment. Unfortunately, the numer of live births after ART remains still low. Over the past three decades, physicians have tried to improve infertility diagnosis and increase its successful treatment. An effort aimed at increasing effectivenes of diagnosis resulted in hypothesis that one of probable reasons of infertility may be the occurrence of microclots, which worsen implantation and embryos development. There are currently no published studies describing the effects of different ovarian hyperstimulation protocols on hemostasis (coagulation and fibrinolysis).
The parameters of thrombin generation and efficiency of fibrinolysis will be evaluated in women qualified for ovarian hyperstimulation. The study may improve the effectiveness of ART.
- Conditions
- Fibrin Blood Clot, Infertility, Female, Endometriosis
- Being tested
- fibrin clot properties
- Keywords
- coagulation, fibrinolysis, ovarian hyperstimulation, infertility
- Medical subject headings
- Infertility, Female, Endometriosis, Thrombosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrin clot propertiesDiagnostic test
Assessment of thrombin generation and efficiency of fibrinolysis.
| Study group | Role | What they receive |
|---|---|---|
| Long protocol | Active comparator | Ovarian hyperstimulation started on day 2 or 3 of the cycle with daily subcutaneous injections of recombinant human FSH (follitropin α, Gonal F®, Merck Serono) and/or urinary human menopausal gonadotropin (menotropin, Menopur®, Ferring GmbH) or mixed recombinant human FSH/LH (Pergoveris®, Merck Serono) with a starting dose of 87.5-250 IE/day Receives: Diagnostic Test: fibrin clot properties |
| Short protocol | Active comparator | Ovarian hyperstimulation with a GnRH-antagonist consisted of the use of ganirelix (Orgalutran®, MSD) from the 6th day of stimulation until it's end at the daily dose of 0.25 mg Receives: Diagnostic Test: fibrin clot properties |
| Clomiphene citrate | Active comparator | Ovarian stimulation with clomiphene citrate (Clostilbegyt®, EGIS) 50 mg daily per os form 3rd to 7th day of the cycle Receives: Diagnostic Test: fibrin clot properties |
| Letrozole | Active comparator | Ovarian stimulation with letrozole (Lametta®, Vipharm) 2.5 mg daily per os form 3rd to 7th day of the cycle Receives: Diagnostic Test: fibrin clot properties |
| Gonadotropins | Active comparator | Ovarian hyperstimulation started on day 2 or 3 of the cycle with daily subcutaneous injections of recombinant human FSH (follitropin α, Gonal F®, Merck Serono). Receives: Diagnostic Test: fibrin clot properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrin clot properties before and after the ovarian hyperstimulation.
Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment.
Measured: 4 months
Secondary outcomes (1)
Endometriosis and fibrin clot properties.
Changes of fibrin clot properties before and after ovarian hyperstimulation in women with endometriosis - Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment.
Measured: 1 cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start18 Nov 2019
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibrin Blood ClotStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Piróg, MD, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166825
- Sponsor's protocol ID
- 292/B/2014/MP
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2019
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pirog M, Jach R, Zabczyk M, Natorska J. Unfavorably altered fibrin clot properties in women with unexplained infertility: association with pregnancy outcomes. Arch Gynecol Obstet. 2026 Apr 27;313(1):173. doi: 10.1007/s00404-026-08418-y.
PubMed 42043574Pirog M, Kacalska-Janssen O, Jach R, Wyroba J, Chrostowski B, Zabczyk M, Natorska J. GnRH Antagonist Protocol Enhances Coagulation During Controlled Ovarian Stimulation for IVF. Reprod Sci. 2022 Dec;29(12):3521-3531. doi: 10.1007/s43032-022-01026-6. Epub 2022 Jul 12.
PubMed 35821349
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Ovarian Hyperstimulation Protocols on Coagulation and Fibrinolysis.
- ClinicalTrials.gov ID
- NCT04166825
- Acronym / sponsor ID
- 292/B/2014/MP
- Conditions
- Fibrin Blood Clot, Infertility, Female, Endometriosis
- Keywords
- coagulation, fibrinolysis, ovarian hyperstimulation, infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 18 Nov 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 impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women.
Comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility.
Detailed description
Infertility is a common problem. Assisted reproductive techniques (ART) increases the chance of getting pregnant by couples undergoing such treatment. Unfortunately, the numer of live births after ART remains still low. Over the past three decades, physicians have tried to improve infertility diagnosis and increase its successful treatment. An effort aimed at increasing effectivenes of diagnosis resulted in hypothesis that one of probable reasons of infertility may be the occurrence of microclots, which worsen implantation and embryos development. There are currently no published studies describing the effects of different ovarian hyperstimulation protocols on hemostasis (coagulation and fibrinolysis).
The parameters of thrombin generation and efficiency of fibrinolysis will be evaluated in women qualified for ovarian hyperstimulation. The study may improve the effectiveness of ART.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Long protocol | Active comparator | Diagnostic Test: fibrin clot propertiesOvarian hyperstimulation started on day 2 or 3 of the cycle with daily subcutaneous injections of recombinant human FSH (follitropin α, Gonal F®, Merck Serono) and/or urinary human menopausal gonadotropin (menotropin, Menopur®, Ferring GmbH) or mixed recombinant human FSH/LH (Pergoveris®, Merck Serono) with a starting dose of 87.5-250 IE/day |
| Short protocol | Active comparator | Diagnostic Test: fibrin clot propertiesOvarian hyperstimulation with a GnRH-antagonist consisted of the use of ganirelix (Orgalutran®, MSD) from the 6th day of stimulation until it's end at the daily dose of 0.25 mg |
| Clomiphene citrate | Active comparator | Diagnostic Test: fibrin clot propertiesOvarian stimulation with clomiphene citrate (Clostilbegyt®, EGIS) 50 mg daily per os form 3rd to 7th day of the cycle |
| Letrozole | Active comparator | Diagnostic Test: fibrin clot propertiesOvarian stimulation with letrozole (Lametta®, Vipharm) 2.5 mg daily per os form 3rd to 7th day of the cycle |
| Gonadotropins | Active comparator | Diagnostic Test: fibrin clot propertiesOvarian hyperstimulation started on day 2 or 3 of the cycle with daily subcutaneous injections of recombinant human FSH (follitropin α, Gonal F®, Merck Serono). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertility defined based on the WHO 2010 criteria
Key exclusion criteria (14 listed)
- ovarian involvement
- oral contraceptives use within previous 3 months
- dienogest therapy within 3 months until ART
- thrombotic events in the medical history
- severe hypertension
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 |
|---|---|---|
| fibrin clot propertiesAssessment of thrombin generation and efficiency of fibrinolysis. | Diagnostic test | Clomiphene citrate, Gonadotropins, Letrozole, Long protocol, Short protocol |
Primary outcome
Fibrin clot properties before and after the ovarian hyperstimulation.
Time frame: 4 months
Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment.
1 secondary outcome
Endometriosis and fibrin clot properties.
Time frame: 1 cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Derived from this study: PubMed 42043574Pirog M, Jach R, Zabczyk M, Natorska J. Unfavorably altered fibrin clot properties in women with unexplained infertility: association with pregnancy outcomes. Arch Gynecol Obstet. 2026 Apr 27;313(1):173. doi: 10.1007/s00404-026-08418-y.
- Derived from this study: PubMed 35821349Pirog M, Kacalska-Janssen O, Jach R, Wyroba J, Chrostowski B, Zabczyk M, Natorska J. GnRH Antagonist Protocol Enhances Coagulation During Controlled Ovarian Stimulation for IVF. Reprod Sci. 2022 Dec;29(12):3521-3531. doi: 10.1007/s43032-022-01026-6. Epub 2022 Jul 12.
- Individual participant dataSharing planned: No
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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.
Department of Gynecological Endocrinology Jagiellonian University Medical College
Krakow, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fibrin clot properties in people with Fibrin Blood Clot and Infertility, Female, run by Jagiellonian University at 1 site in Poland.
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 1 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrin clot properties before and after the ovarian hyperstimulation. (time frame: 4 months). 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 NCT04166825, which also lists 2 linked publications.
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 5 Dec 2025.