Clinical trial NCT04166825: Ovarian Hyperstimulation and Fibrin Clot Properties.
Official title: The Impact of Different Ovarian Hyperstimulation Protocols on Coagulation and Fibrinolysis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibrin Blood Clot
Infertility, Female
Endometriosis
Keywords: coagulation
fibrinolysis
ovarian hyperstimulation
infertility
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Fibrin clot properties before and after the ovarian hyperstimulation.
timeFrame: 4 months
Secondary outcomes:
measure: Endometriosis and fibrin clot properties.
timeFrame: 1 cycle
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Department of Gynecological Endocrinology Jagiellonian University Medical College
state: Małopolska
Study officials:
References:
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.