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

NCT ID: NCT02503371

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-09-30

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

Conditions

Fertilization in Vitro and Blood Coagulation Factors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women under IVF stimulation at the begining and end

Coagulation parameters will be measured for all parturients at the beginning and conclusion of an IVF simulation cycle with the use of thromboelastogram

Blood coagulation anyalsis by Thromboelastogram

Intervention Type: 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

Interventions

Blood coagulation anyalsis by Thromboelastogram

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

sharonorbach

Dr. Sharon Orbach

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beilinson hospital

Petach Tikvah, , Israel

Countries

Israel

Other Identifiers

0332-11-RMC

Identifier Type: -

Identifier Source: org_study_id