How ovarian stimulation affects blood clot (fibrin) properties
Official title: The Impact of Different Ovarian Hyperstimulation Protocols on Coagulation and Fibrinolysis.
Run by Jagiellonian University · NCT04166825 · Data updated 2026-11-12
This trial will test whether different ovarian stimulation methods change blood clotting and the body's ability to break down clots in women with infertility preparing for assisted reproductive treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow, Małopolska) |
| Status | Recruiting |
| Started | November 18, 2019 |
| Main results expected | January 2026 |
| Study ends | January 2026 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT04166825 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women meeting WHO 2010 criteria for infertility who are scheduled for ovarian hyperstimulation for assisted reproductive techniques and who meet the study's medical eligibility criteria.
✕Probably not a fit
People with known thrombotic conditions, recent hormonal treatments, pregnancy, major excluded comorbidities, or those not undergoing ovarian hyperstimulation are unlikely to benefit from this specific study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares thrombin generation and fibrinolysis parameters in women with infertility who are scheduled for ovarian hyperstimulation as part of assisted reproductive techniques. Blood samples will be taken around the stimulation period and analyzed for fibrin clot structure, thrombin formation, and clot lysis efficiency. Different ovarian stimulation protocols will be compared to determine their effects on coagulation and the efficiency of fibrinolysis. The aim is to see whether microclot formation could be linked to implantation problems and to inform protocol choice.
Why it matters
Potential benefit: If successful, the findings could help tailor ovarian stimulation protocols to reduce harmful microclots and improve implantation and live birth rates after ART.
How similar studies have gone: There are currently no published studies directly comparing the effects of different ovarian hyperstimulation protocols on coagulation and fibrinolysis, so this work is largely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Department of Gynecological Endocrinology Jagiellonian University Medical College
Krakow, Małopolska, Poland Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.