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Hysteroscopic Assessment of Fallopian Tubal Patency

NCT ID: NCT02005263

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

621 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-11-06

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Menorrhagia

Keywords

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Hysteroscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Salpingography

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.

Group Type EXPERIMENTAL

Salpingography

Intervention Type PROCEDURE

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.

Interventions

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Salpingography

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.

Intervention Type PROCEDURE

Other Intervention Names

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Parryscope technique

Eligibility Criteria

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Inclusion Criteria

1. 18 - 50 years old
2. Able to give consent
3. Must have a uterus
4. 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
5. Negative test prior to procedure

Exclusion Criteria

1. Pregnancy
2. Active lower and upper genital tract infection
3. Patients with allergies to hysterosalpingogram contrast will not be exposed to a contrast material to which they are allergic
4. Premenarchal or postmenopausal
5. Unable to read English at a 6th grade level or above
6. History of endometrial Ablation
7. Asherman's syndrome \> Stage 1
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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John Preston Parry, MD, MPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John P. Parry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28843382 (View on PubMed)

Other Identifiers

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2013-0230

Identifier Type: -

Identifier Source: org_study_id