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

Fertilization in Vitro and Blood Coagulation Factors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503371
• Other study ID #: 0332-11-RMC
• Status: Completed
• Phase: N/A
• First received: July 12, 2015
• Last updated: July 17, 2015
• Start date: December 2011
• Est. completion date: September 2014

Study information

• Verified date: July 2015
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fertilization in Vitro and Blood Coagulation Factors

Intervention

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

Locations

Country	Name	City	State
Israel	Beilinson hospital	Petach tikvah

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of fibrin function in parturients undergoing IVF by Thromboelastogram		one year	No
Primary	Measurement of thrombocyte function in parturients undergoing IVF by Thromboelastogram		one year	No
Primary	Measurement of global hemostatic statis in parturients undergoing IVF by Thromboelastogram		one year	No
Primary	Measurement of fibrinolysisin parturients undergoing IVF by Thromboelastogram		one year	No