NCT02146248

HSG and Tubal Patency Study

Tubal Patency During the Menstrual Cycle and During Treatment With Hormonal Contraceptives: a Pilot Study in Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Jeffrey Jensen · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The investigators' research group is working to develop a highly effective, low cost non-surgical method of permanent contraception for women. To support this goal, we need to know more about the normal fallopian tube (tube that passes the egg from the ovary into the womb). The purpose of this study is to learn about how menstrual cycles and hormonal contraceptives affect tubal patency. Normally there is an opening between the tube and uterus to permit the flow of fluid and cells. If this opening is blocked, this can result in infertility. Tubal patency is when a woman's fallopian tubes are not blocked. Tubal patency is determined by an x-ray test called a hystero-(uterus)salpingo-(fallopian tube)graphy (HSG). HSG is a standard radiological imaging study that is used to determine if the fallopian tubes are open and free of disease. It is commonly done in women with an infertility diagnosis. The investigators usually do this test in the first 10 days of the menstrual cycle. Sometimes the tubes will appear to be blocked on the HSG when they are actually open. The timing of the HSG study during the menstrual cycle, or the use of hormonal contraception may make a difference in whether the tubes appear blocked on the HSG when they are actually patent. The results of the HSG test provide a good model for how our nonsurgical permanent contraception method might work. The investigators think that if the tubes are not patent, that our treatment will not work as well. Therefore, in this study we want to learn if menstrual cycle timing or current hormonal contraception use will affect the patency of the tubes as assessed by the HSG. The investigators want to examine the same women to see if tubal patency is changes during the menstrual cycle and during the use of a birth control pill and the birth control shot.

Conditions

• Tubal Patency

Interventions

Type	Name	Description
DRUG	combined oral contraceptive	combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption
DRUG	DepoProvera	injectable hormonal contraceptive

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-01-01
• Completion: 2015-04-01
• First posted: 2014-05-23
• Last updated: 2017-03-22
• Results posted: 2017-02-20

Locations

1 site across 1 country: United States