Cardiac Output Monitoring in IVF Patients

September 22, 2019 updated by: Rabin Medical Center

Cardiac Output Monitoring in Patients Undergoing In Vitro Fertilization by Noninvasive Cardiac Impendence: A Prospective Observational Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

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
        • Recruiting
        • Beilinson Hospital
        • Sub-Investigator:
          • Galia Oren

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
On the day of ovum pickup prior to their entrance to the operating theater.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1-3rd day of the menstrual cycle prior to treatment with gonadotropins

Collaborators and Investigators

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

Sponsor

Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

June 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (ACTUAL)

October 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 22, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 172-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

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.

Clinical Trials on Fertilization in Vitro

Clinical Trials on NICaS bioimpedance system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe