InfertilityNCT04415489
SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF
A study testing Office hysteroscopy in people with Infertility, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of intra-uterine pathology, it is not often used as an initial screening tool because of provider concerns about in-office tolerability… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Office hysteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18 - 50
- Patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles
Who cannot join
- Clinical or radiologic suspicion of intrauterine pathology including myomas, severe intrauterine adhesions or retained products of conception
- Those with medical criteria not suitable office hysteroscopy due to requirement of advanced tools or preparation not available in the office such as history of bleeding disorder or medical co-morbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF: a Randomized Control Trial
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of intra-uterine pathology, it is not often used as an initial screening tool because of provider concerns about in-office tolerability, operating room costs, and use of anesthesia. The investigators aim to compare SIS and office hysteroscopy with respect to patient and provider satisfaction. Additionally, the investigators aim to assess the capability of office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and reduce delays and supernumerary procedures.
Read the detailed description
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. SIS is often performed as a screening tool in the office for uterine evaluation since it is straight-forward to perform, well-tolerated has low overhead cost. If uterine pathology is suspected on SIS, subsequent hysteroscopy is typically performed in the operating room. Hysteroscopy remains the gold standard for diagnosis of intra-uterine pathology and offers the opportunity for intervention at time of diagnosis, but often is not used as the initial screening tool because of provider concerns about in-office tolerability, equipment cost and maintenance. Technology advancements, however, has introduced an affordable, disposable, small caliber hysteroscopes with an operative channel to make it possible for this type of assessment to be performed in the office setting with the addition of a 'see and treat' modality. If used to perform initial uterine cavity evaluation, hysteroscopy may offer expedited diagnosis, treatment, and avoidance of general anesthesia. If superior specificity is demonstrated, it may also lower the false positive rate, preventing unnecessary delays to a patient's projected treatment plan, and unnecessary exposure to anesthesia risks. To date, no randomized control trials have compared the satisfaction of patients and providers to saline infusion sonography versus office hysteroscopy without anesthesia in initial cavity evaluation with the ability to immediately address intra-uterine pathology.
- Conditions
- Infertility
- Being tested
- Office hysteroscopy
- Keywords
- Assisted Reproduction
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office hysteroscopyDevice
Also called LiNA OperaScope
Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
| Study group | Role | What they receive |
|---|---|---|
| Office Hysteroscopy | Active comparator | Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity. Receives: Device: Office hysteroscopy |
| Saline Infusion Sonography (SIS) | No intervention | This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
Measured: Immediately following imaging modality (less than 30 minutes)
Pain Scores
Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).
Measured: Immediately following imaging modality (less than 30 minutes)
Provider Satisfaction
Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
Measured: Immediately following imaging modality (less than 30 minutes)
Secondary outcomes (5)
Time to Complete
Length of time to complete procedure in minutes
Measured: During the allotted procedure only
Number of Patients Requiring Secondary Procedure
Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure.
Measured: Through study completion, up to 1 year
Time to Infertility Treatment
Number of days to achieve planned fertility treatment
Measured: Through study completion, up to 1 year
Positive Predictive Value of SIS
Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy
Measured: Through study completion, up to 1 year
Ability to Manage Pathology With Office Hysteroscopy
Number of participants with pathology on hysteroscopy successfully managed within same procedure
Measured: During the allotted procedure only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start6 Dec 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing satisfaction between saline infusion sonography and office hysteroscopy for screening evaluation of the uterine cavity prior to embryo transfer.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Moustafa, MD, Principal investigator, University of North Carolina, Chapel HillLinnea Goodman, MD, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415489
- Sponsor's protocol ID
- 18-3077
- Status last verified
- Mar 2021
- First submitted
- 26 May 2020
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Moustafa S, Rosen E, Goodman L. Patient and provider satisfaction with saline ultrasound versus office hysteroscopy for uterine cavity evaluation prior to in vitro fertilization: a randomized controlled trial. J Assist Reprod Genet. 2021 Mar;38(3):627-634. doi: 10.1007/s10815-021-02065-9. Epub 2021 Feb 1.
PubMed 33527249
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04415489
- Acronym / sponsor ID
- 18-3077
- Conditions
- Infertility
- Keywords
- Assisted Reproduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of intra-uterine pathology, it is not often used as an initial screening tool because of provider concerns about in-office tolerability, operating room costs, and use of anesthesia. The investigators aim to compare SIS and office hysteroscopy with respect to patient and provider satisfaction. Additionally, the investigators aim to assess the capability of office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and reduce delays and supernumerary procedures.
Detailed description
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. SIS is often performed as a screening tool in the office for uterine evaluation since it is straight-forward to perform, well-tolerated has low overhead cost. If uterine pathology is suspected on SIS, subsequent hysteroscopy is typically performed in the operating room. Hysteroscopy remains the gold standard for diagnosis of intra-uterine pathology and offers the opportunity for intervention at time of diagnosis, but often is not used as the initial screening tool because of provider concerns about in-office tolerability, equipment cost and maintenance. Technology advancements, however, has introduced an affordable, disposable, small caliber hysteroscopes with an operative channel to make it possible for this type of assessment to be performed in the office setting with the addition of a 'see and treat' modality. If used to perform initial uterine cavity evaluation, hysteroscopy may offer expedited diagnosis, treatment, and avoidance of general anesthesia. If superior specificity is demonstrated, it may also lower the false positive rate, preventing unnecessary delays to a patient's projected treatment plan, and unnecessary exposure to anesthesia risks. To date, no randomized control trials have compared the satisfaction of patients and providers to saline infusion sonography versus office hysteroscopy without anesthesia in initial cavity evaluation with the ability to immediately address intra-uterine pathology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing satisfaction between saline infusion sonography and office hysteroscopy for screening evaluation of the uterine cavity prior to embryo transfer.
| Arm | Type | Receives |
|---|---|---|
| Office Hysteroscopy | Active comparator | Device: Office hysteroscopyUse of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity. |
| Saline Infusion Sonography (SIS) | No intervention | –This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 18 - 50
- Patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles
Key exclusion criteria (2 listed)
- Clinical or radiologic suspicion of intrauterine pathology including myomas, severe intrauterine adhesions or retained products of conception
- Those with medical criteria not suitable office hysteroscopy due to requirement of advanced tools or preparation not available in the office such as history of bleeding disorder or medical co-morbidity
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 |
|---|---|---|
| Office hysteroscopyAlso: LiNA OperaScopeUse of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers. | Device | Office Hysteroscopy |
Primary outcome
Patient Satisfaction
Time frame: Immediately following imaging modality (less than 30 minutes)
Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
Pain Scores
Time frame: Immediately following imaging modality (less than 30 minutes)
Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).
Provider Satisfaction
Time frame: Immediately following imaging modality (less than 30 minutes)
Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
5 secondary outcomes
Time to Complete
Time frame: During the allotted procedure only
Number of Patients Requiring Secondary Procedure
Time frame: Through study completion, up to 1 year
Time to Infertility Treatment
Time frame: Through study completion, up to 1 year
Positive Predictive Value of SIS
Time frame: Through study completion, up to 1 year
Ability to Manage Pathology With Office Hysteroscopy
Time frame: During the allotted procedure only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33527249Moustafa S, Rosen E, Goodman L. Patient and provider satisfaction with saline ultrasound versus office hysteroscopy for uterine cavity evaluation prior to in vitro fertilization: a randomized controlled trial. J Assist Reprod Genet. 2021 Mar;38(3):627-634. doi: 10.1007/s10815-021-02065-9. Epub 2021 Feb 1.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Sarah Moustafa, MD principal investigator
University of North Carolina, Chapel Hill
Linnea Goodman, MD study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Office hysteroscopy in people with Infertility, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 19 May 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Satisfaction (time frame: Immediately following imaging modality (less than 30 minutes)). The study lists 3 primary outcomes in all. 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 NCT04415489, 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 19 May 2021.