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Ovarian Hyperstimulation and Fibrin Clot Properties.

Primary Purpose

Fibrin Blood Clot, Infertility, Female, Endometriosis

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
fibrin clot properties
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fibrin Blood Clot focused on measuring coagulation, fibrinolysis, ovarian hyperstimulation, infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Gynecological Endocrinology Jagiellonian University Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Long protocol

Short protocol

Clomiphene citrate

Letrozole

Gonadotropins

Arm Description

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

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

Ovarian stimulation with clomiphene citrate (Clostilbegyt®, EGIS) 50 mg daily per os form 3rd to 7th day of the cycle

Ovarian stimulation with letrozole (Lametta®, Vipharm) 2.5 mg daily per os form 3rd to 7th day of the cycle

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).

Outcomes

Primary Outcome Measures

Fibrin clot properties before and after the ovarian hyperstimulation.
Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment.

Secondary Outcome Measures

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.

Full Information

First Posted
November 13, 2019
Last Updated
March 30, 2021
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT04166825
Brief Title
Ovarian Hyperstimulation and Fibrin Clot Properties.
Official Title
The Impact of Different Ovarian Hyperstimulation Protocols on Coagulation and Fibrinolysis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
July 17, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrin Blood Clot, Infertility, Female, Endometriosis
Keywords
coagulation, fibrinolysis, ovarian hyperstimulation, infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long protocol
Arm Type
Active Comparator
Arm Description
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
Arm Title
Short protocol
Arm Type
Active Comparator
Arm Description
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
Arm Title
Clomiphene citrate
Arm Type
Active Comparator
Arm Description
Ovarian stimulation with clomiphene citrate (Clostilbegyt®, EGIS) 50 mg daily per os form 3rd to 7th day of the cycle
Arm Title
Letrozole
Arm Type
Active Comparator
Arm Description
Ovarian stimulation with letrozole (Lametta®, Vipharm) 2.5 mg daily per os form 3rd to 7th day of the cycle
Arm Title
Gonadotropins
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
fibrin clot properties
Intervention Description
Assessment of thrombin generation and efficiency of fibrinolysis.
Primary Outcome Measure Information:
Title
Fibrin clot properties before and after the ovarian hyperstimulation.
Description
Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Endometriosis and fibrin clot properties.
Description
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.
Time Frame
1 cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Gynecological Endocrinology Jagiellonian University Medical College
City
Kraków
State/Province
Małopolska
ZIP/Postal Code
30-501
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35821349
Citation
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.
Results Reference
derived

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Ovarian Hyperstimulation and Fibrin Clot Properties.

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