Cardiac Output Monitoring in IVF Patients

NCT03713723 | Unknown

• 1 other identifier: 172-17
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertilization in Vitro

Outcome Measures

Primary Outcomes (1)

• Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor

  On the day of ovum pickup prior to their entrance to the operating theater.

Secondary Outcomes (1)

• Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor

  1-3rd day of the menstrual cycle prior to treatment with gonadotropins

Study Arms (1)

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

Interventions

NICaS bioimpedance system DEVICE

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

Patients undergoing IVF treatment with hemodynamic monitoring

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Beilinson hospital

Petach Tikvah, Israel

RECRUITING

Related Publications (28)

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Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: June 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 24, 2019

Record last verified: 2018-10

Locations

IL (1)