Automated Folliculometry Using Five-Dimensional Ultrasound
Conditions
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.
Interventions
None listed
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
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.
Participants by arm
| Arm | Count |
|---|---|
| Folliculometry in Women With Unexplained Infertility 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. | 67 |
| Total | 67 |
Baseline characteristics
| Characteristic | Folliculometry in Women With Unexplained Infertility |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants |
| Region of Enrollment Egypt | 67 Count of Participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 |
Outcome results
Primary
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.
Time frame: 10th day of the menstrual cycle
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Folliculometry in Women With Unexplained Infertility | The Mean Follicular Diameter by Two-Dimensional Ultrasound | 8.41 mm | Standard Deviation 3.79 |
Secondary
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)
Time frame: 10th day of the menstrual cycle
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Folliculometry in Women With Unexplained Infertility | The Mean Follicular Diameter by Five-Dimensional Ultrasound | 8.46 mm | Standard Deviation 3.89 |
Secondary
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.
Time frame: 10th day of the menstrual cycle
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Folliculometry in Women With Unexplained Infertility | The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound | 1193.29 mm^3 | Standard Deviation 987.46 |