Completed

NCT Number: NCT02503371

The Effect of In Vitro Fertilization on Coagulation Parameters as Measured by Thromboelastogram

Since its introduction in 1978, over 3.75 million babies have been born using in vitro fertilization (IVF). Maturing ovarian follicles lead to a large rise in estrogen to supra-physiological levels . This increase in estrogen has been shown to cause a hypercoagulable state, leading at times to arterial and venous thrombosis.(Thromboelastogram (TEG) is a point of care whole blood hemostatsis analyzer mimicking in vivo conditions and measuring visco elastic properties of the clot. The TEG shows effect of most of the components of hemostatsis: coagulation factors, fibrinogen, platelets and fibrinolysis. Components of TEG include R, reflecting coagulation factor cascade, alpha angle and K measurements reflecting fibrin function, MA reflecting mostly thrombocyte function, coagulation index (CI) measuring global hemostatic statis and LY30 measuring fibrinolysis.

In this study the investigators would like to measure serum estrogen levels and (TEG) in parturients at the beginning and conclusion of an IVF simulation cycle and evaluate how it's influnence on coagulation parameters, and wheather or not a large sample size will effect primary outcomes.

Secondarily the investigators would like to see if estrogen levels are predictors of coagulation parameters and see if age influences TEG parameters

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Key information

Conditions

Fertilization in Vitro and Blood Coagulation Factors

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Beilinson hospital

Petach Tikvah, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parturients above 18 undergoing in-vitro fertilization at rabin medical center, with the ability to comply with the study requriments.

Exclusion criteria

Parturients were excluded if they had;

hypertension,
diabetes,
anticoagulation therapy or any platelet disorder,
or were not able to comply with study requirments.

Treatment and study plan

Blood coagulation anyalsis by Thromboelastogram

Other

Two blood tests will be taken during routine tests from all parturient s undergoing IVF treatment before starting gonadotropins treatment (the first few days of menstruation) and at the height of hormone therapy prior to egg retrieval Coagulation parameters will be measured by the use of Thromboelastogram

Primary outcomes

Measurement of fibrin function in parturients undergoing IVF by Thromboelastogram

Time frame: one year
Measurement of thrombocyte function in parturients undergoing IVF by Thromboelastogram

Time frame: one year
Measurement of global hemostatic statis in parturients undergoing IVF by Thromboelastogram

Time frame: one year
Measurement of fibrinolysisin parturients undergoing IVF by Thromboelastogram

Time frame: one year

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jul 21, 2015
Registry last updated: Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.