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Cardiac Output Monitoring in IVF Patients

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ClinicalTrials.gov Identifier: NCT03713723
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:

In this study we aim to evaluate hemodynamic effects of IVF treatment, with the use of the non invasive NICaS bioimpendence monitor.

Our study's primary end point is to evaluate the hemodynamic profile with the use of NICaS whole body impedance cardiography that occur throughout the IVF cycle in patients undergoing controlled ovarian stimulation during IVF treatment.

Secondary endpoints include:

Women will be asked to grade their pain score and level of anxiety by the use of the visual analogue score elicited throughout the study observation points, in order to examine whether pain scores and anxiety levels correlate with the hemodynamic changes throughout an IVF treatment cycle.


Condition or disease Intervention/treatment
Fertilization in Vitro Device: NICaS bioimpedance system

Detailed Description:

This is a prospective, observational, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. Fifty healthy woman (≤45 years old) undergoing IVF treatment will be enrolled following filling out an informed consent form.

Study procedure:

Women will be recruited in the IVF department upon consulting with the fertility specialist. Following signed informed consent, patients' blood pressure will be measured using a non-invasive upper arm blood pressure. Cardiovascular monitoring will be carried out using non-invasive NICAS cardiac impedance cardiography by the use of two electrodes stickers which are pasted on the wrists for 6 minutes.

Monitoring will be performed on:

  1. 1-3rd day of the menstrual cycle prior to treatment with gonadotropins
  2. On the day of ovulation triggering
  3. On the day of ovum pickup prior to their entrance to the operating theater.
  4. On the day of embryo transfer.

IVF Protocol:

The antagonist protocol consists of daily gonadotropin stimulation from day 3 or 4 of menstruation. In addition, once the leading follicle reached 13-14 mm, daily injections of Cetrotide 0.25 mg (Serono, Switzerland) or Orgalutran 0.25 mg (N.V. Organon, the Netherlands) are given and until the day of hCG (Ovitrelle, Serono, Switzerland) injection. Gonadotropin stimulation will consist of recombinant FSH (Gonal F, Serono, Postfach, Switzerland; or Puregon, N.V. Organon, Oss, The Netherlands), alone or in combination with urinary gonadotropins (Menopur, Ferring, Kiel, Germany). During treatment, the ovarian response will be monitored by serial vaginal ultrasound measurements of follicular growth and serum E2 level every 1-3 days, starting on the fourth or fifth day of stimulation, gonadotropin dosage will be adjusted accordingly. When at least 3 follicles reached at least 17 millimeters, hCG is injected and thirty six hours after hCG injection, follicles will be aspirated in the operating room.

Data Collection:

Recorded data will include:

  • Cardiac Output and its derivate including: systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and total peripheral resistance (TPR).
  • Demographic and obstetric age, weight, height, current hemoglobin, comorbidities, regular medication and other obstetric data.

Data Handling Data collection for all participants in the study will be done anonymously. All hemodynamic data collected will be done by a trained member of the research team. All collected data will be coded and recorded on the eCRF NICaS monitor, and will be accessible only to a member of the research team.

Study duration:

The study duration for each participant will be throughout the IVF cycle of treatment approximately 6 weeks.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Output Monitoring in Patients Undergoing In Vitro Fertilization by Noninvasive Cardiac Impendence: A Prospective Observational Study
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 2019

Group/Cohort Intervention/treatment
Patients undergoing IVF treatment with hemodynamic monitoring
Fifty health women aged 18-45 undergoing their first, second or third cycle of IVF treatment will be monitored with the non invasive NICaS bioimpedance
Device: NICaS bioimpedance system
NICaS is a bioimpedance system focusing on noninvasive assessment and monitoring of cardiovascular, respiratory, and fluid parameters.Cardiovascular monitoring will be carried out using non-invasive NICAS cardiac impedance cardiography by the use of two electrodes stickers which are pasted on the wrists for 6 minutes




Primary Outcome Measures :
  1. Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor [ Time Frame: On the day of ovum pickup prior to their entrance to the operating theater. ]

Secondary Outcome Measures :
  1. Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor [ Time Frame: 1-3rd day of the menstrual cycle prior to treatment with gonadotropins ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a prospective, observational, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. Fifty healthy woman (≤45 years old) undergoing IVF treatment will be enrolled following filling out an informed consent form.
Criteria

Inclusion Criteria:

Women above 18-45 undergoing their first, second or third cycle of IVF treatment in Beilinson Hospital following obtaining written informed consents forums with the ability to comply with the study requirements will be included in our study.

Exclusion Criteria:

  • Women under age 18
  • Women with polycystic ovarian syndrome
  • Women with cardiomyopathy
  • Women with history of chronic hypertension
  • Women with a congenital heart disease
  • Women who are not able to comply with study requirements and can't sign an informed consent forum.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713723


Locations
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Israel
Beilinson hospital Recruiting
Petach tikvah, Israel
Contact: Sharon Orbach, MD    972-54-538-3093    sharonorbach@yahoo.com   
Principal Investigator: Sharon Orbach-zinger         
Sub-Investigator: Galia Oren         
Sponsors and Collaborators
Rabin Medical Center

Publications:

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03713723     History of Changes
Other Study ID Numbers: 172-17
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No