NCT04166825

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

6.1 years

First QC Date

November 13, 2019

Last Update Submit

November 28, 2025

Conditions

Fibrin Blood ClotInfertility, FemaleEndometriosis

Keywords

coagulationfibrinolysisovarian hyperstimulationinfertility

Outcome Measures

Primary Outcomes (1)

  • Fibrin clot properties before and after the ovarian hyperstimulation.

    Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment.

    4 months

Secondary Outcomes (1)

  • Endometriosis and fibrin clot properties.

    1 cycle

Study Arms (5)

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

Diagnostic Test: fibrin clot properties

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

Diagnostic Test: fibrin clot properties

Clomiphene citrate

ACTIVE COMPARATOR

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

Letrozole

ACTIVE COMPARATOR

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

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).

Diagnostic Test: fibrin clot properties

Interventions

fibrin clot propertiesDIAGNOSTIC_TEST

Assessment of thrombin generation and efficiency of fibrinolysis.

Clomiphene citrateGonadotropinsLetrozoleLong protocolShort protocol

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • infertility defined based on the WHO 2010 criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecological Endocrinology Jagiellonian University Medical College

Krakow, Małopolska, 30-501, Poland

RECRUITING

Related Publications (1)

  • 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: 35821349DERIVED

MeSH Terms

Conditions

Infertility, FemaleEndometriosisThrombosisInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 18, 2019

Study Start

November 18, 2019

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)