Ovarian Hyperstimulation and Fibrin Clot Properties.

Jagiellonian University

Status: Unknown

Conditions: Fibrin Blood Clot; Endometriosis; Infertility, Female

Treatments: Diagnostic Test: fibrin clot properties

Study type: Interventional

Funder types: Other

Identifiers

NCT04166825

292/B/2014/MP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 5 patient groups

Long protocol

Active Comparator group

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

Treatment:

Diagnostic Test: fibrin clot properties

Short protocol

Active Comparator group

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

Treatment:

Diagnostic Test: fibrin clot properties

Clomiphene citrate

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: fibrin clot properties

Letrozole

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: fibrin clot properties

Gonadotropins

Active Comparator group

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).

Treatment:

Diagnostic Test: fibrin clot properties