Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332027
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-19
Brief Title:
Accuracy of Hystro-Salpingo-Foam-Sonography HYFOSY as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Accuracy of Hystro-Salpingo-Foam-Sonography HYFOSY as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tubal patency testing is an essential part of female subfertility evaluation Tubal abnormalities are seen in 30-40 of female subfertility patients Laparoscopy with chromopertubation is considered to be the gold standard diagnostic procedure
Laparoscopy is an invasive test with a risk of intra-abdominal bleeding visceral damage and risks related to general anaesthesia
Traditionally HysterosalpingographyHSG is a less invasive less expensive first-step alternative which has been used for decades with disadvantages such as radiation exposure discomfort or even abdominal pain
Hysterosalpingo-Contrast Sonography HyCoSy was introduced as an alternative using either contrast media or saline The accuracy of HyCoSy is comparable to that of HSG and LSC being reference standards for tubal patency testingHowever hyperechogenic contrast media such as Echovist_ Schering AG Berlin and SonoVue_ Bracco Milanare either no longer available or not licensed for tubal patency testing
Hysterosalpingo-Foam Sonography HyFoSy was developed as an alternative for contrast HyCoSy and was introduced in 2010 as a first-line office tubal patency testFoam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel containing hydroxyethyl cellulose and glycerolIQMedical Ventures BV Rotterdam TheNetherlands with 5ml purified ExEm_-water
The ExEm_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes which is an advantage over saline In a review on safety aspects and side effects of ExEm-gel it was considered to be appropriate and safe for tubal patency testing
In 2017 HyLiFoSy combined with power Doppler PDHyLiFoSy-PD technique was described as a possibly less painful and easier to detect on ultrasound alternativeto HyFoSy and HyCoSy which can be used whenever the contrast media used with both are either unavailable or is relatively expensive Ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography HyCoSy hysterosalpingo-foam sonography HyFoSy and hysterosalpingo-lidocaine-foam sonography HyLiFoSyand have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 838 to 100 with HSG and from 781 to9691 with lap-and-dye test
In addition they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it in the clinicians own office with it consequently being time efficient Finally some studies have shown an increase in the rate of post-procedure gestation
Laparoscopy is an invasive test with a risk of intra-abdominal bleeding visceral damage and risks related to general anaesthesia
Traditionally HysterosalpingographyHSG is a less invasive less expensive first-step alternative which has been used for decades with disadvantages such as radiation exposure discomfort or even abdominal pain
Hysterosalpingo-Contrast Sonography HyCoSy was introduced as an alternative using either contrast media or saline The accuracy of HyCoSy is comparable to that of HSG and LSC being reference standards for tubal patency testingHowever hyperechogenic contrast media such as Echovist_ Schering AG Berlin and SonoVue_ Bracco Milanare either no longer available or not licensed for tubal patency testing
Hysterosalpingo-Foam Sonography HyFoSy was developed as an alternative for contrast HyCoSy and was introduced in 2010 as a first-line office tubal patency testFoam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel containing hydroxyethyl cellulose and glycerolIQMedical Ventures BV Rotterdam TheNetherlands with 5ml purified ExEm_-water
The ExEm_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes which is an advantage over saline In a review on safety aspects and side effects of ExEm-gel it was considered to be appropriate and safe for tubal patency testing
In 2017 HyLiFoSy combined with power Doppler PDHyLiFoSy-PD technique was described as a possibly less painful and easier to detect on ultrasound alternativeto HyFoSy and HyCoSy which can be used whenever the contrast media used with both are either unavailable or is relatively expensive Ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography HyCoSy hysterosalpingo-foam sonography HyFoSy and hysterosalpingo-lidocaine-foam sonography HyLiFoSyand have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 838 to 100 with HSG and from 781 to9691 with lap-and-dye test
In addition they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it in the clinicians own office with it consequently being time efficient Finally some studies have shown an increase in the rate of post-procedure gestation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None