How ovarian stimulation affects blood clot (fibrin) properties
The Impact of Different Ovarian Hyperstimulation Protocols on Coagulation and Fibrinolysis.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow, Małopolska) |
| Trial ID | NCT04166825 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Krakow, Małopolska
- Department of Gynecological Endocrinology Jagiellonian University Medical College — Krakow, Małopolska, Poland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.