Infertility, FemaleNCT06332027
Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients
A study testing Hystro-Salpingo-Foam-Sonography (HYFOSY) in people with Infertility, Female, run by Sohag University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Hystro-Salpingo-Foam-Sonography (HYFOSY)
- Type of treatment
- Pill or oral medicine
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40
- Sexually active
- Infertility or subfertility primary and secondary
Who cannot join
- Current pregnancy
- Heavy menstrual bleeding
- Peivic inflammatory disease
- Allergy to lidocaine
Trial locations and contacts
1 site in 1 country.
Salah R Ahmed, professor contact
About this study
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.
Read more
Traditionally, Hysterosalpingography(HSG) 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 testing.However, hyperechogenic contrast media such as Echovist_ (Schering AG, Berlin) and SonoVue_ (Bracco, Milan)are 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 test.Foam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel (containing hydroxyethyl cellulose and glycerol,IQMedical 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 (PD)(HyLiFoSy-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 (HyLiFoSy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with HSG, and from 78.1 to96.91% 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 clinician's own office with it consequently being time efficient. Finally, some studies have shown an increase in the rate of post-procedure gestation.
- Conditions
- Infertility, Female
- Being tested
- Hystro-Salpingo-Foam-Sonography (HYFOSY)
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hystro-Salpingo-Foam-Sonography (HYFOSY)Diagnostic test
antibiotic prophylaxis oral azithromycin 500 mg per day 3 days the patient lie in dorsal lithotomy cervix visualized by Cusco speculum, cleaned with betadine 7% 6-Fr pediatric Foley's balloon catheter will be introduced into the cervical canal inflated with 2 ml of saline to prevent backflow of contrast through the cervix TV-US probe will be introduced,The foam will be created by mixing 3-4ml of 2% rialocaine gel (lidocaine hydrochloride 2%, Riadh Pharma,Saudi Arabia) with 16-17 ml of saline shaking the mixture between two syringes until a whitish suspension 20ml of lidocaine foam infused into uterine cavity observing the flow in each fallopian tube using greyscale and power Doppler (PD) 2D ultrasound Foam flow over the whole length of the tube fimbrial outflow, or peritoneal spillage of contrast provided evidence of tubal patency Patients observed for15-30 min for any complication or increase in pain Comparison between results and that of laparoscopy in operative list
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy of HyFoSy in the assessment of tubal patency
by comparing it with the reference standard of LDT, using the measures of diagnostic accuracy: sensitivity, specificity,positive predictive value (PPV), negative predictive value (NPV), positive likelihood ration (LR), negative LR, and overall accuracy.
Measured: 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332027
- Sponsor's protocol ID
- Soh-Med-24-03-03MD
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fertility problems: assessment and treatment. London: National Institute for Health and Care Excellence (NICE); 2017 Sep. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK554709/
PubMed 32134604Exalto N, Emanuel MH. Clinical Aspects of HyFoSy as Tubal Patency Test in Subfertility Workup. Biomed Res Int. 2019 Jul 8;2019:4827376. doi: 10.1155/2019/4827376. eCollection 2019.
PubMed 31360713Melcer Y, Zilberman Sharon N, Nimrodi M, Pekar-Zlotin M, Gat I, Maymon R. Hysterosalpingo-Foam Sonography for the Diagnosis of Tubal Occlusion: A Systematic Review and Meta-analysis. J Ultrasound Med. 2021 Oct;40(10):2031-2037. doi: 10.1002/jum.15607. Epub 2020 Dec 28.
PubMed 33368463Piccioni MG, Riganelli L, Filippi V, Fuggetta E, Colagiovanni V, Imperiale L, Caccetta J, Panici PB, Porpora MG. Sonohysterosalpingography: Comparison of foam and saline solution. J Clin Ultrasound. 2017 Feb;45(2):67-71. doi: 10.1002/jcu.22412. Epub 2016 Oct 18.
PubMed 27753111
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients
- ClinicalTrials.gov ID
- NCT06332027
- Acronym / sponsor ID
- Soh-Med-24-03-03MD
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, Hysterosalpingography(HSG) 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 testing.However, hyperechogenic contrast media such as Echovist_ (Schering AG, Berlin) and SonoVue_ (Bracco, Milan)are 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 test.Foam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel (containing hydroxyethyl cellulose and glycerol,IQMedical 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 (PD)(HyLiFoSy-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 (HyLiFoSy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with HSG, and from 78.1 to96.91% 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 clinician's own office with it consequently being time efficient. Finally, some studies have shown an increase in the rate of post-procedure gestation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-40
- Sexually active
- Infertility or subfertility primary and secondary
Key exclusion criteria (4 listed)
- Current pregnancy
- Heavy menstrual bleeding
- Peivic inflammatory disease
- Allergy to lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hystro-Salpingo-Foam-Sonography (HYFOSY)antibiotic prophylaxis oral azithromycin 500 mg per day 3 days the patient lie in dorsal lithotomy cervix visualized by Cusco speculum, cleaned with betadine 7% 6-Fr pediatric Foley's balloon catheter will be introduced into the cervical canal inflated with 2 ml of saline to prevent backflow of contrast through the cervix TV-US probe will be introduced,The foam will be created by mixing 3-4ml of 2% rialocaine gel (lidocaine hydrochloride 2%, Riadh Pharma,Saudi Arabia) with 16-17 ml of saline shaking the mixture between two syringes until a whitish suspension 20ml of lidocaine foam infused into uterine cavity observing the flow in each fallopian tube using greyscale and power Doppler (PD) 2D ultrasound Foam flow over the whole length of the tube fimbrial outflow, or peritoneal spillage of contrast provided evidence of tubal patency Patients observed for15-30 min for any complication or increase in pain Comparison between results and that of laparoscopy in operative list | Diagnostic test | – |
Primary outcome
the accuracy of HyFoSy in the assessment of tubal patency
Time frame: 1yr
by comparing it with the reference standard of LDT, using the measures of diagnostic accuracy: sensitivity, specificity,positive predictive value (PPV), negative predictive value (NPV), positive likelihood ration (LR), negative LR, and overall accuracy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 32134604Fertility problems: assessment and treatment. London: National Institute for Health and Care Excellence (NICE); 2017 Sep. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK554709/
- Background: PubMed 31360713Exalto N, Emanuel MH. Clinical Aspects of HyFoSy as Tubal Patency Test in Subfertility Workup. Biomed Res Int. 2019 Jul 8;2019:4827376. doi: 10.1155/2019/4827376. eCollection 2019.
- Background: PubMed 33368463Melcer Y, Zilberman Sharon N, Nimrodi M, Pekar-Zlotin M, Gat I, Maymon R. Hysterosalpingo-Foam Sonography for the Diagnosis of Tubal Occlusion: A Systematic Review and Meta-analysis. J Ultrasound Med. 2021 Oct;40(10):2031-2037. doi: 10.1002/jum.15607. Epub 2020 Dec 28.
- Background: PubMed 27753111Piccioni MG, Riganelli L, Filippi V, Fuggetta E, Colagiovanni V, Imperiale L, Caccetta J, Panici PB, Porpora MG. Sonohysterosalpingography: Comparison of foam and saline solution. J Clin Ultrasound. 2017 Feb;45(2):67-71. doi: 10.1002/jcu.22412. Epub 2016 Oct 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah R Ahmed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hystro-Salpingo-Foam-Sonography (HYFOSY) in people with Infertility, Female, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Ahmed, Assistant lecturer (01092200298, ahmed.hamad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the accuracy of HyFoSy in the assessment of tubal patency (time frame: 1yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332027, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.