InfertilityNCT02005263
Hysteroscopic Assessment of Fallopian Tubal Patency
A study testing Salpingography in people with Infertility and Menorrhagia, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Disease of the fallopian tubes is one of the most common reasons for infertility. The most common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses concurrent uterine disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility, Menorrhagia
- What is being tested?
- Salpingography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 6 Nov 2017
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 50 years old
- Able to give consent
- Must have a uterus
- Must have documented negative testing for gonorrhea and chlamydia within the past year or previously negative when tested with a current partner in a monogamous relationship
- Negative test prior to procedure
Who cannot join
- Pregnancy
- Active lower and upper genital tract infection
- Patients with allergies to hysterosalpingogram contrast will not be exposed to a contrast material to which they are allergic
- Premenarchal or postmenopausal
- Unable to read English at a 6th grade level or above
- History of endometrial Ablation
- Asherman's syndrome > Stage 1
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Disease of the fallopian tubes is one of the most common reasons for infertility. The most common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses concurrent uterine disease. We propose using a less painful technique (through modified office hysteroscopy) for tubal assessment that can be performed in the office rather than hospital radiology and that uses gold standard technology for identifying coexisting uterine conditions.
- Conditions
- Infertility, Menorrhagia
- Being tested
- Salpingography
- Keywords
- Hysteroscopy
- Medical subject headings
- Infertility, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalpingographyProcedure or surgery
Also called Parryscope technique
Infusion of typically 1-2 mL of air bubbles in to the uterine cavity to assess whether they disappear through the ostia in to the Fallopian tubes.
| Study group | Role | What they receive |
|---|---|---|
| Salpingography | Experimental | Infusion of air bubbles through Fallopian tubes with hysteroscopic visualization; typically 1-2 mL is infused. This is less than that typically used in the established technique of sonosalpingography. Receives: Procedure: Salpingography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hysteroscopic assessment of tubal patency
Patients undergoing the procedure will be informed based on the findings as to whether or not it is believed that their Fallopian tubes are patent
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion16 Oct 2017
- Study completion6 Nov 2017
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Preston Parry, MD, MPH, University of Mississippi Medical Center
- Investigators
- John P. Parry, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005263
- Sponsor's protocol ID
- 2013-0230
- Status last verified
- Nov 2017
- First submitted
- 3 Dec 2013
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Parry JP, Riche D, Rushing J, Linton B, Butler V, Lindheim SR. Performing the Parryscope technique gently for office tubal patency assessment. Fertil Steril. 2017 Oct;108(4):718. doi: 10.1016/j.fertnstert.2017.07.1159. Epub 2017 Aug 31.
PubMed 28843382
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Assessment of Fallopian Tubal Patency
- ClinicalTrials.gov ID
- NCT02005263
- Acronym / sponsor ID
- 2013-0230
- Conditions
- Infertility, Menorrhagia
- Keywords
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 9 Dec 2013 (estimated)
- 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.
Disease of the fallopian tubes is one of the most common reasons for infertility. The most common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses concurrent uterine disease. We propose using a less painful technique (through modified office hysteroscopy) for tubal assessment that can be performed in the office rather than hospital radiology and that uses gold standard technology for identifying coexisting uterine conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salpingography | Experimental | Procedure: SalpingographyInfusion of air bubbles through Fallopian tubes with hysteroscopic visualization; typically 1-2 mL is infused. This is less than that typically used in the established technique of sonosalpingography. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 - 50 years old
- Able to give consent
- Must have a uterus
- Must have documented negative testing for gonorrhea and chlamydia within the past year or previously negative when tested with a current partner in a monogamous relationship
- Negative test prior to procedure
Key exclusion criteria (7 listed)
- Pregnancy
- Active lower and upper genital tract infection
- Patients with allergies to hysterosalpingogram contrast will not be exposed to a contrast material to which they are allergic
- Premenarchal or postmenopausal
- Unable to read English at a 6th grade level or above
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 |
|---|---|---|
| SalpingographyAlso: Parryscope techniqueInfusion of typically 1-2 mL of air bubbles in to the uterine cavity to assess whether they disappear through the ostia in to the Fallopian tubes. | Procedure or surgery | Salpingography |
Primary outcome
Hysteroscopic assessment of tubal patency
Time frame: 2 years
Patients undergoing the procedure will be informed based on the findings as to whether or not it is believed that their Fallopian tubes are patent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Derived from this study: PubMed 28843382Parry JP, Riche D, Rushing J, Linton B, Butler V, Lindheim SR. Performing the Parryscope technique gently for office tubal patency assessment. Fertil Steril. 2017 Oct;108(4):718. doi: 10.1016/j.fertnstert.2017.07.1159. Epub 2017 Aug 31.
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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.
John P. Parry, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salpingography in people with Infertility and Menorrhagia, run by University of Mississippi Medical Center 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 5 inclusion and 7 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 8 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hysteroscopic assessment of tubal patency (time frame: 2 years). 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 NCT02005263, 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 8 Nov 2017.