Trial Outcomes & Findings for Automated Folliculometry Using Five-Dimensional Ultrasound (NCT NCT02642575)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

67 participants

Primary outcome timeframe

10th day of the menstrual cycle

Results posted on

2017-06-12

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	67
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Automated Folliculometry Using Five-Dimensional Ultrasound

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Folliculometry in Women With Unexplained Infertility n=67 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Egypt	67 Count of Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Folliculometry in Women With Unexplained Infertility n=67 Participants 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.
The Mean Follicular Diameter by Two-Dimensional Ultrasound	8.41 mm Standard Deviation 3.79

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Folliculometry in Women With Unexplained Infertility n=67 Participants 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.
The Mean Follicular Diameter by Five-Dimensional Ultrasound	8.46 mm Standard Deviation 3.89

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Folliculometry in Women With Unexplained Infertility n=67 Participants 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.
The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound	1193.29 mm^3 Standard Deviation 987.46

Adverse Events

Folliculometry in Women With Unexplained Infertility

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Rehab Mohamed Abdelrahman

Ain Shams University

Phone: +201004992772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place