Automated Folliculometry Using Five-Dimensional Ultrasound

The aim of the study to evaluate Five-Dimensional Ultrasound in automated measurement of ovarian follicles with controlled ovarian stimulation in contrast to the conventional 2D ultrasound

Study Overview

• Status: Completed
• Conditions: Automated Folliculometry Using Five-Dimensional Ultrasound

Detailed Description

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

72 women will be recruited from the the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

All cases will be subjected to:

full history taking including patient's age, parity,last menstrual period , past history of medical disorders, clinical examinations (General and abdominal).

Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of ovarian follicles after controlled ovarian stimulation by clomid 50 mg5×2×1 The automated software allows for automated three-dimensional follicular measurement.The software then analyzes the volume and automatically identifies all of the follicles in the ovary. The software also automatically generates several volumetric parameters of each and every identified follicle.

• Study Type: Observational
• Enrollment (Actual): 67

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

67 women will be recruited from the the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

Description

Inclusion Criteria:

• all women between 25 to 35 years of age
• all women have a normal body mass index(18-25kg/M^2)
• regular menstrual cycles
• all women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound U/S

Exclusion Criteria:

1. medical disorders
2. obesity. BMI>30

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mean Follicular Diameter by Two-Dimensional Ultrasound	All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Two Dimensional Ultrasound was done. Each follicle was assessed by measuring the maximal diameters on three orthogonal planes. The mean of three diameters was calculated.	10th day of the menstrual cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mean Follicular Diameter by Five-Dimensional Ultrasound	All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Five Dimensional Ultrasound was done. Five Dimensional Ultrasound automatically identifies hypoechogenic follicles within the captured ovarian volume and generates a set of measurements for each follicle. These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD)	10th day of the menstrual cycle
The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound	All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Five Dimensional Ultrasound was done. Five Dimensional Ultrasound automatically identifies hypoechogenic follicles within the captured ovarian volume and generates a set of measurements for each follicle including the volume-based diameter (dV) of the follicle. The volume calculation is based on the voxel count within the identified follicle. It therefore represents a true measure of follicular volume.	10th day of the menstrual cycle

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (ESTIMATE): December 30, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 5D Folliculometry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The aim of the study to evaluate Five-Dimensional Ultrasound in automated measurement of ovarian follicles with controlled ovarian stimulation in contrast to the conventional 2D ultrasound