Ovarian Hyperstimulation and Fibrin Clot Properties.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fibrin Blood Clot Infertility, Female Endometriosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Intervention Type DIAGNOSTIC_TEST

Assessment of thrombin generation and efficiency of fibrinolysis.

Interventions

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fibrin clot properties

Assessment of thrombin generation and efficiency of fibrinolysis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No