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

Completed

• Conditions: Fertilization in Vitro and Blood Coagulation Factors

• Registration Number: NCT02503371
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-07
• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-17
• Last Update Submitted: 2015-07-17
• Study First Posted: 2015-07-21
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of fibrin function in parturients undergoing IVF by Thromboelastogram	one year
Measurement of thrombocyte function in parturients undergoing IVF by Thromboelastogram	one year
Measurement of global hemostatic statis in parturients undergoing IVF by Thromboelastogram	one year
Measurement of fibrinolysisin parturients undergoing IVF by Thromboelastogram	one year

Trial Locations

Locations (1)

Beilinson hospital; 🇮🇱 Petach tikvah, Israel