Tubal Factor InfertilityNCT05419921
Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hysterosalpingography in Tubal Patency Assessment to the Gold Standard of Laparoscopy and Dye Testing
An observational study of Tubal Factor Infertility, run by Cairo University at 1 site in Egypt.
Trial summary
This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Tubal Factor Infertility
- What is being tested?
- Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 31 Oct 2023
- Phase
- Observational
- 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
- Adult
Study population: Women in the reproductive age group between 18- and 40-years old presenting with primary or secondary infertility who underwent HSG in the previous 5 years as a part of their infertility work-up with availability of good-quality HSG images, \& did not get pregnant in this period, and gave no history of incidences that might affect their tubes, such as : abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion. Women fitting these inclusion criteria and scheduled for LDT as part of their infertility work up will be considered. HyLiFoSy-PD will be carried out few days before the already scheduled LDT.
Who may be able to join
- Age group (18-40)
- Informed signed Written consent.
- Scheduled for LDT as a part of their infertility management
- Have undergone HSG in the previous 5 years with the availability of good-quality HSG images.
- No incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
Who cannot join
- LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology
- Lack of good-quality HSG images.
- Withdrawal of consent.
- Using contraception
- Women outside reproductive age
- Known allergy to lidocaine
Show all 9Show fewer
- Active pelvic inflammatory disease
- Undiagnosed genital tract bleeding.
- Evident tubal pathology (such as hydrosalpinx) or pregnancy diagnosed by transvaginal ultrasound (TV-US) prior to performing HyLiFoSy-PD 10- Incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
Trial locations and contacts
1 site in 1 country.
About this study
This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing.
- Conditions
- Tubal Factor Infertility
- Being tested
- Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)Diagnostic test
Women in the reproductive age group between 18- and 40-years old presenting with primary or secondary infertility who underwent HSG in the previous 5 years as a part of their infertility work-up with availability of good-quality HSG images, \& did not get pregnant in this period, and gave no history of incidences that might affect their tubes, such as : abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
Women fitting these inclusion criteria and scheduled for LDT as part of their infertility work up will be considered. HyLiFoSy-PD will be carried out few days before the already scheduled LDT.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
Measured: July 2022- June 2024
Secondary outcomes (4)
Evaluate the procedure associated pain
Pain will be assessed during the procedure (after insertion of Foley's catheter, during injection of lidocaine-made gel foam) using the verbal rating scale (VRS). Interpretation will be like: no pain, mild pain, moderate pain, severe pain.
Measured: July 2022- June 2024
Evaluate the procedure duration
Duration is calculated in minutes, from the introduction of Cusco speculum to the exit of Foley's catheter
Measured: July 2022- June 2024
Percentage of failed or inconclusive attempts and possible reasons for that
Measured: July 2022- June 2024
Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation
Measured: July 2022- June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Feb 2018
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: The data collection team stopped recruiting cases.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal Factor InfertilityStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Tarek Elkhateb, NewGiza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419921
- Sponsor's protocol ID
- IT28052022
- Status last verified
- Dec 2024
- First submitted
- 8 Jun 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hysterosalpingography in Tubal Patency Assessment to the Gold Standard of Laparoscopy and Dye Testing
- ClinicalTrials.gov ID
- NCT05419921
- Acronym / sponsor ID
- IT28052022
- Conditions
- Tubal Factor Infertility
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The data collection team stopped recruiting cases.
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Jun 2022 (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.
This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women in the reproductive age group between 18- and 40-years old presenting with primary or secondary infertility who underwent HSG in the previous 5 years as a part of their infertility work-up with availability of good-quality HSG images, \& did not get pregnant in this period, and gave no history of incidences that might affect their tubes, such as : abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion. Women fitting these inclusion criteria and scheduled for LDT as part of their infertility work up will be considered. HyLiFoSy-PD will be carried out few days before the already scheduled LDT.
Key inclusion criteria (5 listed)
- Age group (18-40)
- Informed signed Written consent.
- Scheduled for LDT as a part of their infertility management
- Have undergone HSG in the previous 5 years with the availability of good-quality HSG images.
- No incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
Key exclusion criteria (9 listed)
- LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology
- Lack of good-quality HSG images.
- Withdrawal of consent.
- Using contraception
- Women outside reproductive age
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 |
|---|---|---|
| Hysterosalpingo-lidocaine-foam-sonography combined with power doppler (HyLiFoSy-PD)Women in the reproductive age group between 18- and 40-years old presenting with primary or secondary infertility who underwent HSG in the previous 5 years as a part of their infertility work-up with availability of good-quality HSG images, \& did not get pregnant in this period, and gave no history of incidences that might affect their tubes, such as : abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion. Women fitting these inclusion criteria and scheduled for LDT as part of their infertility work up will be considered. HyLiFoSy-PD will be carried out few days before the already scheduled LDT. | Diagnostic test | – |
Primary outcome
Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
Time frame: July 2022- June 2024
4 secondary outcomes
Evaluate the procedure associated pain
Time frame: July 2022- June 2024
Evaluate the procedure duration
Time frame: July 2022- June 2024
Percentage of failed or inconclusive attempts and possible reasons for that
Time frame: July 2022- June 2024
Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation
Time frame: July 2022- June 2024
Results and safety
The study was stopped early (reason given: The data collection team stopped recruiting cases.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes
Related trials for Tubal Factor Infertility
Recruiting
Comprehensive Assessment System for Fallopian Tube Function and Clinical Study on Individualized Treatment Strategies
Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor Infertility
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tubal Factor Infertility, run by Cairo 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Dec 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?
The study was stopped early (reason given: The data collection team stopped recruiting cases.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. (time frame: July 2022- June 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2024.