Fertilization in Vitro and Blood Coagulation FactorsNCT02503371
The Effect of In Vitro Fertilization on Coagulation Parameters as Measured by Thromboelastogram
An observational study of Fertilization in Vitro and Blood Coagulation Factors, run by Rabin Medical Center at 1 site in Israel.
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 . Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertilization in Vitro and Blood Coagulation Factors
- What is being tested?
- Blood coagulation anyalsis by Thromboelastogram
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Parturients undergoing in-vitro fertilization treatment
Who may be able to join
- Parturients above 18 undergoing in-vitro fertilization at rabin medical center, with the ability to comply with the study requriments.
Who cannot join
- Parturients were excluded if they had;
- hypertension,
- diabetes,
- anticoagulation therapy or any platelet disorder,
- or were not able to comply with study requirments.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Blood coagulation anyalsis by Thromboelastogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood coagulation anyalsis by ThromboelastogramOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood coagulation anyalsis by Thromboelastogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of fibrin function in parturients undergoing IVF by Thromboelastogram
Measured: one year
Measurement of thrombocyte function in parturients undergoing IVF by Thromboelastogram
Measured: one year
Measurement of global hemostatic statis in parturients undergoing IVF by Thromboelastogram
Measured: one year
Measurement of fibrinolysisin parturients undergoing IVF by Thromboelastogram
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startDec 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertilization in Vitro and Blood Coagulation FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sharonorbach, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503371
- Sponsor's protocol ID
- 0332-11-RMC
- Status last verified
- Jul 2015
- First submitted
- 12 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of In Vitro Fertilization on Coagulation Parameters as Measured by Thromboelastogram
- ClinicalTrials.gov ID
- NCT02503371
- Acronym / sponsor ID
- 0332-11-RMC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women under IVF stimulation at the begining and end | – | Other: Blood coagulation anyalsis by ThromboelastogramCoagulation parameters will be measured for all parturients at the beginning and conclusion of an IVF simulation cycle with the use of thromboelastogram |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Parturients undergoing in-vitro fertilization treatment
Key inclusion criteria (1 listed)
- Parturients above 18 undergoing in-vitro fertilization at rabin medical center, with the ability to comply with the study requriments.
Key exclusion criteria (5 listed)
- Parturients were excluded if they had;
- hypertension,
- diabetes,
- anticoagulation therapy or any platelet disorder,
- or were not able to comply with study requirments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood coagulation anyalsis by ThromboelastogramTwo 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 | Other | Women under IVF stimulation at the begining and end |
Primary outcome
Measurement of fibrin function in parturients undergoing IVF by Thromboelastogram
Time frame: one year
Measurement of thrombocyte function in parturients undergoing IVF by Thromboelastogram
Time frame: one year
Measurement of global hemostatic statis in parturients undergoing IVF by Thromboelastogram
Time frame: one year
Measurement of fibrinolysisin parturients undergoing IVF by Thromboelastogram
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertilization in Vitro and Blood Coagulation Factors, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of fibrin function in parturients undergoing IVF by Thromboelastogram (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.