Cardiac Output Monitoring in IVF Patients

Fertilization in Vitro Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713723
• Other study ID #: 172-17
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fertilization in Vitro

Intervention

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

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, 

References & Publications (28)

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Salmassi A, Mettler L, Jonat W, Buck S, Koch K, Schmutzler AG. Circulating level of macrophage colony-stimulating factor can be predictive for human in vitro fertilization outcome. Fertil Steril. 2010 Jan;93(1):116-23. doi: 10.1016/j.fertnstert.2008.09.083. Epub 2008 Nov 8. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor		1-3rd day of the menstrual cycle prior to treatment with gonadotropins