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NCT Number: NCT04166825

Ovarian Hyperstimulation and Fibrin Clot Properties.

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynecological Endocrinology Jagiellonian University Medical College

Krakow, Małopolska, 30-501, Poland

Location status: Recruiting

Location contact

Joanna Natorska, MD, PhD

SUB_INVESTIGATOR

Magdalena Piróg, MD, PhD

CONTACT

[email protected]

604514915

Olga Kacalska - Janssen, MD, PhD

SUB_INVESTIGATOR

Robert Jach, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fibrin clot properties

Diagnostic Test

Assessment of thrombin generation and efficiency of fibrinolysis.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2019
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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