Automated Folliculometry Using Five-Dimensional Ultrasound

Completed

• Conditions: Automated Folliculometry Using Five-Dimensional Ultrasound

• Registration Number: NCT02642575
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-30
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Results First Submitted: 2017-03-28
• Results First Submitted QC: 2017-03-28
• Status Verified: 2017-05
• Results First Posted: 2017-05-08
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Mean Follicular Diameter by Two-Dimensional Ultrasound	10th day of the menstrual cycle	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.

Secondary Outcome Measures

Name	Time	Method
The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound	10th day of the menstrual cycle	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.
The Mean Follicular Diameter by Five-Dimensional Ultrasound	10th day of the menstrual cycle	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)