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Recruiting NCT04166825

Ovarian Hyperstimulation and Fibrin Clot Properties.

No phase Interventional Fibrin Blood Clot Infertility, Female Endometriosis

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fibrin clot properties.
Who it may be relevant to
Registry conditions: Fibrin Blood Clot, Infertility, Female, Endometriosis. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Impact of Different Ovarian Hyperstimulation Protocols on Coagulation and Fibrinolysis.

Overview

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.

Interventions

  • Diagnostic test fibrin clot properties
    Assessment of thrombin generation and efficiency of fibrinolysis.

Primary outcome measures

  • Fibrin clot properties before and after the ovarian hyperstimulation. [Time frame: 4 months]
Secondary outcome measures (1)
  • Endometriosis and fibrin clot properties. [Time frame: 1 cycle]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Poland · 1 center
  • Department of Gynecological Endocrinology Jagiellonian University Medical College — Krakow

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. PMID 42043574
  • 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 41888469
  • 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. PMID 35821349

Identifiers

NCT: NCT04166825 · 292/B/2014/MP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗