DIAGNOSTIC_TEST
fibrin clot properties
Assessment of thrombin generation and efficiency of fibrinolysis.
Ovarian Hyperstimulation and Fibrin Clot Properties.
Status
Recruiting
Phase
Not applicable
Enrollment
300
Locations
1
Results
Not posted
Publications
3
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Nov 18, 2019
Study start
Nov 18, 2019
Primary completion
Jan 2026
Study completion
Jan 2026
Results posted
Not reported
Registry updated
Dec 5, 2025
Outcomes
What the study measures.
Primary outcomes
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.
Secondary outcomes
Endometriosis and fibrin clot properties.
Time frame · 1 cycle
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 40 Years
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: * infertility defined based on the WHO 2010 criteria Exclusion Criteria: * 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 * 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.
Study locations
1 registered sites.
Poland. Showing up to 24 locations stored in the fast local snapshot.
Department of Gynecological Endocrinology Jagiellonian University Medical College
Krakow, Małopolska, Poland
Publications
Results and literature.
PMID 42043574 ↗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.PMID 41888469 ↗Pirog M, Jach R, Zabczyk M, Natorska J. Prothrombotic fibrin clot phenotype in pregnant women after ovarian stimulation: associations with neuropeptides. Hormones (Athens). 2026 Mar 26. doi: 10.1007/s42000-026-00774-3. Online ahead of print.PMID 35821349 ↗Pirog 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.
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