Hysteroscopic Assessment of Fallopian Tubal Patency

NCT02005263 | Completed

• 1 other identifier: 2013-0230
• Study Type: interventional
• Target: 621
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (1)

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.

Procedure: Salpingography

Interventions

Salpingography 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.

Also known as: Parryscope technique

Salpingography

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• 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.

  PMID: 28843382 DERIVED

MeSH Terms

Conditions

Infertility; Menorrhagia

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• John P. Parry, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: October 16, 2017
• Study Completion: November 6, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

US (1)