NCT Number: NCT02642575
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
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Notify MeKey information
Age range
18 year–38 year
Sex eligibility
Female
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
- medical disorders
- obesity. BMI>30
Treatment and study plan
Primary outcomes
-
The Mean Follicular Diameter by Two-Dimensional Ultrasound
Time frame: 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 outcomes
-
The Mean Follicular Diameter by Five-Dimensional Ultrasound
Time frame: 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)
-
The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Dec 30, 2015
- Registry last updated
- Jun 12, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.