Ovarian Hyperstimulation and Fibrin Clot Properties.

November 28, 2025 updated by: Magdalena Piróg, MD, Jagiellonian University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Małopolska
      • Krakow, Małopolska, Poland, 30-501
        • Recruiting
        • Department of Gynecological Endocrinology Jagiellonian University Medical College
        • Contact:
        • Sub-Investigator:
          • Olga Kacalska - Janssen, MD, PhD
        • Sub-Investigator:
          • Joanna Natorska, MD, PhD
        • Sub-Investigator:
          • Robert Jach, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Long protocol
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
Diagnostic test: fibrin clot properties
Assessment of thrombin generation and efficiency of fibrinolysis.
Active Comparator: Short protocol
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
Diagnostic test: fibrin clot properties
Assessment of thrombin generation and efficiency of fibrinolysis.
Active Comparator: Clomiphene citrate
Ovarian stimulation with clomiphene citrate (Clostilbegyt®, EGIS) 50 mg daily per os form 3rd to 7th day of the cycle
Diagnostic test: fibrin clot properties
Assessment of thrombin generation and efficiency of fibrinolysis.
Active Comparator: Letrozole
Ovarian stimulation with letrozole (Lametta®, Vipharm) 2.5 mg daily per os form 3rd to 7th day of the cycle
Diagnostic test: fibrin clot properties
Assessment of thrombin generation and efficiency of fibrinolysis.
Active Comparator: Gonadotropins
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).
Diagnostic test: fibrin clot properties
Assessment of thrombin generation and efficiency of fibrinolysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Estimated)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292/B/2014/MP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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