Female InfertilityNCT03777358
Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women
An observational study of Female Infertility, run by Hatem AbuHashim at 1 site in Egypt.
Trial summary
Hysteroscopy has now become a gold-standard technique carried out for uterine cavity assessment in infertile women. Apart from direct visualizing of the endometrium by the naked eye, pathologies missed by other modalities of investigation can be picked up and managed appropriately. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- 3D-TVS
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 2021
- 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
- No healthy volunteers
- Adult
Study population: Infertile women (primary or secondary) aged between 18 and 40 years.
Who may be able to join
- Infertile women (primary or secondary)
- Age between 18 and 40 years.
Who cannot join
- age<18 years and˃ 40 years.
- pelvic inflammatory disease.
- .Active uterine bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Comparing Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women
Hysteroscopy has now become a gold-standard technique carried out for uterine cavity assessment in infertile women. Apart from direct visualizing of the endometrium by the naked eye, pathologies missed by other modalities of investigation can be picked up and managed appropriately. Unfortunately, the procedure itself is not free from complications e.g. perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and considered as an invasive procedure.
Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in identifying uterine cavity abnormalities due to its ability to obtain a view of three different planes of the uterus, which could be used to locate the position of intracavitary pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have 41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but its sensitivity, specificity and accuracy still a matter of debate and warrants more evaluation.
- Conditions
- Female Infertility
- Being tested
- 3D-TVS
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-TVSDevice
The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then hysteroscopy will be performed
| Study group | Role | What they receive |
|---|---|---|
| Three-dimensional transvaginal ultrasonography (3D-TVS) | The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then, hysteroscopy will be performed. Receives: Device: 3D-TVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of 3D-TVS
The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women.
Measured: At 1 week postmenstrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Jan 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatem AbuHashim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatem AbuHashim, Mansoura University
- Investigators
- Hatem Abu Hashim, MD. FRCOG. PhD, Study chair, Faculty of Medicine, Mansoura UniversityMohamed Fekry, MSc, Principal investigator, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777358
- Sponsor's protocol ID
- MD.18.10.99
- Status last verified
- Jul 2019
- First submitted
- 14 Dec 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmadi F, Rashidy Z, Haghighi H, Akhoond M, Niknejadi M, Hemat M, Shamsipour M. Uterine cavity assessment in infertile women: Sensitivity and specificity of three-dimensional Hysterosonography versus Hysteroscopy. Iran J Reprod Med. 2013 Dec;11(12):977-82.
PubMed 24639723
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women
- ClinicalTrials.gov ID
- NCT03777358
- Acronym / sponsor ID
- MD.18.10.99
- Conditions
- Female Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hatem AbuHashimUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 17 Dec 2018 (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.
Hysteroscopy has now become a gold-standard technique carried out for uterine cavity assessment in infertile women. Apart from direct visualizing of the endometrium by the naked eye, pathologies missed by other modalities of investigation can be picked up and managed appropriately. Unfortunately, the procedure itself is not free from complications e.g. perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and considered as an invasive procedure.
Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in identifying uterine cavity abnormalities due to its ability to obtain a view of three different planes of the uterus, which could be used to locate the position of intracavitary pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have 41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but its sensitivity, specificity and accuracy still a matter of debate and warrants more evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three-dimensional transvaginal ultrasonography (3D-TVS) | – | Device: 3D-TVSThe 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then, hysteroscopy will be performed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women (primary or secondary) aged between 18 and 40 years.
Key inclusion criteria (2 listed)
- Infertile women (primary or secondary)
- Age between 18 and 40 years.
Key exclusion criteria (3 listed)
- age<18 years and˃ 40 years.
- pelvic inflammatory disease.
- .Active uterine bleeding
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 |
|---|---|---|
| 3D-TVSThe 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then hysteroscopy will be performed | Device | Three-dimensional transvaginal ultrasonography (3D-TVS) |
Primary outcome
Diagnostic accuracy of 3D-TVS
Time frame: At 1 week postmenstrual
The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 24639723Ahmadi F, Rashidy Z, Haghighi H, Akhoond M, Niknejadi M, Hemat M, Shamsipour M. Uterine cavity assessment in infertile women: Sensitivity and specificity of three-dimensional Hysterosonography versus Hysteroscopy. Iran J Reprod Med. 2013 Dec;11(12):977-82.
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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.
Hatem Abu Hashim, MD. FRCOG. PhD study chair
Faculty of Medicine, Mansoura University
Mohamed Fekry, MSc principal investigator
Faculty of Medicine, Mansoura University
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 Female Infertility, run by Hatem AbuHashim 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 2 inclusion and 3 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 16 Jul 2019. 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?
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 3D-TVS (time frame: At 1 week postmenstrual). 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 NCT03777358, which also lists 1 linked publication.
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 16 Jul 2019.