Ovarian Hyperstimulation and Fibrin Clot Properties.

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04166825
• Other study ID #: 292/B/2014/MP
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2021
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 30, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Fibrin Blood Clot
• Infertility
• Infertility, Female
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Gynecological Endocrinology Jagiellonian University Medical College	Kraków	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 cycle