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

Study Overview

• Status: Completed
• Conditions: Fertilization in Vitro and Blood Coagulation Factors
• Intervention / Treatment: Other: Blood coagulation anyalsis by Thromboelastogram

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Israel
  • Petach tikvah, Israel
    • Beilinson Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Parturients undergoing in-vitro fertilization treatment

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 12, 2015
• First Submitted That Met QC Criteria: July 17, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 0332-11-RMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No