Hysteroscopic Assessment of Fallopian Tubal Patency

University of Mississippi

Status: Completed

Conditions: Infertility; Menorrhagia

Treatments: Procedure: Salpingography

Study type: Interventional

Funder types: Other

Identifiers

NCT02005263

2013-0230

Details and patient eligibility

About

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.

Enrollment: 621 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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621 participants in 1 patient group

Salpingography

Experimental group

Description:

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.

Treatment:

Procedure: Salpingography