Automated Folliculometry Using Five-Dimensional Ultrasound

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02642575
• Collaborator: (none)
• Enrollment: 67
• Duration (Months): 9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 67 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Automated Folliculometry Using Five-Dimensional Ultrasound
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rehab Mohamed Abdelrahman, Principal Investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02642575
• Other Study ID Numbers: 5D Folliculometry
• First Posted: Dec 30, 2015
• Last Update Posted: Jun 12, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

Participant Flow

Recruitment Details	This was a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital from January 2016 to august 2016. 67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.

Arm/Group Title	Folliculometry in Women With Unexplained Infertility
Arm/Group Description	67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, 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.
Period Title: Overall Study
STARTED	67
COMPLETED	67
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Folliculometry in Women With Unexplained Infertility
Arm/Group Description	67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, 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.
Overall Participants	67
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	67 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	67 100%
Male	0 0%
Region of Enrollment (Count of Participants) [Number]
Egypt	67 100%

Outcome Measures

1. Primary Outcome

Title	The Mean Follicular Diameter by Two-Dimensional Ultrasound
Description	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.
Time Frame	10th day of the menstrual cycle

Outcome Measure Data

Analysis Population Description

67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.

Arm/Group Title	Folliculometry in Women With Unexplained Infertility
Arm/Group Description	67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, 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.
Measure Participants	67
Mean (Standard Deviation) [mm]	8.41 (3.79)

2. Secondary Outcome

Title	The Mean Follicular Diameter by Five-Dimensional Ultrasound
Description	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)
Time Frame	10th day of the menstrual cycle

Outcome Measure Data

Analysis Population Description

67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.

Arm/Group Title	Folliculometry in Women With Unexplained Infertility
Arm/Group Description	67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, 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.
Measure Participants	67
Mean (Standard Deviation) [mm]	8.46 (3.89)

3. Secondary Outcome

Title	The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound
Description	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.
Time Frame	10th day of the menstrual cycle

Outcome Measure Data

Analysis Population Description

67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.

Arm/Group Title	Folliculometry in Women With Unexplained Infertility
Arm/Group Description	67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, 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.
Measure Participants	67
Mean (Standard Deviation) [mm^3]	1193.29 (987.46)

Adverse Events

Time Frame	1 year march 2016 to march 2017
Adverse Event Reporting Description	Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were performed and adverse Events Adverse Events were assessed.
Arm/Group Title	Folliculometry in Women With Unexplained Infertility
Arm/Group Description	67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, 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.
All Cause Mortality
	Folliculometry in Women With Unexplained Infertility
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Folliculometry in Women With Unexplained Infertility
	Affected / at Risk (%)	# Events
Total	0/67 (0%)
Other (Not Including Serious) Adverse Events
	Folliculometry in Women With Unexplained Infertility
	Affected / at Risk (%)	# Events
Total	0/67 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.