Ovarian Hyperstimulation and Fibrin Clot Properties.

Not Applicable

• Conditions: Infertility, Female; Endometriosis; Fibrin Blood Clot

• Registration Number: NCT04166825
• Lead Sponsor: Jagiellonian University

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.

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-14
• Study Start: 2019-11-18
• Study First Posted: 2019-11-18
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01
• Primary Completion: 2021-07-17
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fibrin clot properties before and after the ovarian hyperstimulation.	4 months	Coagulation (endogenous thrombin potential) and fibrinolysis (F1+2, clot lysis time)parameters assessment.

Secondary Outcome Measures

Name	Time	Method
Endometriosis and fibrin clot properties.	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.

Trial Locations

Locations (1)

Department of Gynecological Endocrinology Jagiellonian University Medical College; 🇵🇱 Kraków, Małopolska, Poland