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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Clomiphene citrate | Active Comparator | Ovarian stimulation with clomiphene citrate (Clostilbegyt®, EGIS) 50 mg daily per os form 3rd to 7th day of the cycle |
|
| Letrozole | Active Comparator | Ovarian stimulation with letrozole (Lametta®, Vipharm) 2.5 mg daily per os form 3rd to 7th day of the cycle |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fibrin clot properties | Diagnostic Test | Assessment of thrombin generation and efficiency of fibrinolysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibrin clot properties before and after the ovarian hyperstimulation. | Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecological Endocrinology Jagiellonian University Medical College | Recruiting | Krakow | Małopolska | 30-501 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41888469 | Derived | 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. | |
| 35821349 | Derived | 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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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D004715 | Endometriosis |
| D013927 | Thrombosis |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| D000091662 | Genital Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |