Uterine AbnormalityNCT06763380
Comparison of Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality in Patients With Infertility
An observational study of Uterine Abnormality, run by Superior University at 1 site in Pakistan.
Trial summary
The leading issue that every couple is experiencing in present era is infertility and it has become the major problem worldwide. Many hormonal disorders, weight, diet, and uterine abnormalities contributes in infertility. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Abnormality
- What is being tested?
- Ultrasound and ultrasound then hysterosalpingography
- How many people
- 3 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: primary and secondary infertile women using Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality
Who may be able to join
- primary and secondary infertile women
Who cannot join
- Pregnant women. Women with PID
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr. Essa Lab, High Q tower, Jail Road Lahore"
Lahore, Punjab Province
About this study
Official title: Comparison of Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality in Patients With Primary and Secondary Infertility
The leading issue that every couple is experiencing in present era is infertility and it has become the major problem worldwide. Many hormonal disorders, weight, diet, and uterine abnormalities contributes in infertility.
Read the detailed description
To Compare diagnostic effectiveness of Ultrasound and Hysterosalpingography in detecting uterine abnormalities among Primary and Secondary Infertile women.
In order to obtain the necessary results, 73 patients were examined on Ultrasound and then referred for Hysterosalpingography at Radiology Department of Dr.Essa Lab and Punjab Radiology. Patients with Primary and secondary infertility between the age of 18 to 45 were included whereas pregnant women and women with PID and GTI were excluded. The data were collected utilizing the questionnaire and then processed in SPSS version 25.
- Conditions
- Uterine Abnormality
- Being tested
- Ultrasound, ultrasound then hysterosalpingography
- Medical subject headings
- Uterine Anomalies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Detection of uterine abnormalities in patients who are infertile buy using Ultrasound
ultrasound then hysterosalpingographyDiagnostic test
If uterine abnormality could not diagnosed with ultrasound then hysterosalpingography would be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
2D Ultrasound Scan
Uterine anomalies can be diagnosed on routine two-dimensional ultrasound scan
Measured: 12 Months
Hysterosalpingography test
HSG is an x-ray exam of the uterus and fallopian tubes. It uses a special form of x-ray called fluoroscopy and a contrast materia.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start28 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine AbnormalityStudies of the same condition, open and under way.
- More trials run by Superior 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763380
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/012
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality in Patients With Primary and Secondary Infertility
- ClinicalTrials.gov ID
- NCT06763380
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/012
- Conditions
- Uterine Abnormality
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Jan 2025 (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.
The leading issue that every couple is experiencing in present era is infertility and it has become the major problem worldwide. Many hormonal disorders, weight, diet, and uterine abnormalities contributes in infertility.
Detailed description
To Compare diagnostic effectiveness of Ultrasound and Hysterosalpingography in detecting uterine abnormalities among Primary and Secondary Infertile women.
In order to obtain the necessary results, 73 patients were examined on Ultrasound and then referred for Hysterosalpingography at Radiology Department of Dr.Essa Lab and Punjab Radiology. Patients with Primary and secondary infertility between the age of 18 to 45 were included whereas pregnant women and women with PID and GTI were excluded. The data were collected utilizing the questionnaire and then processed in SPSS version 25.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- primary and secondary infertile women using Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality
Key inclusion criteria (1 listed)
- primary and secondary infertile women
Key exclusion criteria (1 listed)
- Pregnant women. Women with PID
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 |
|---|---|---|
| UltrasoundDetection of uterine abnormalities in patients who are infertile buy using Ultrasound | Diagnostic test | – |
| ultrasound then hysterosalpingographyIf uterine abnormality could not diagnosed with ultrasound then hysterosalpingography would be performed | Diagnostic test | – |
Primary outcome
2D Ultrasound Scan
Time frame: 12 Months
Uterine anomalies can be diagnosed on routine two-dimensional ultrasound scan
Hysterosalpingography test
Time frame: 12 Months
HSG is an x-ray exam of the uterus and fallopian tubes. It uses a special form of x-ray called fluoroscopy and a contrast materia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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 Uterine Abnormality, run by Superior University at 1 site in Pakistan.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
2D Ultrasound Scan (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 8 Jan 2025.