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

July 17, 2015 updated by: sharonorbach, Rabin Medical Center

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach tikvah, Israel
        • Beilinson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: one year
one year
Measurement of thrombocyte function in parturients undergoing IVF by Thromboelastogram
Time Frame: one year
one year
Measurement of global hemostatic statis in parturients undergoing IVF by Thromboelastogram
Time Frame: one year
one year
Measurement of fibrinolysisin parturients undergoing IVF by Thromboelastogram
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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