CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
combined oral contraceptive +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02146248
NCT02146248N/ACompleted

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

Jeffrey Jensen·interventional·Posted May 23, 2014·Updated Mar 22, 2017

In Brief

A clinical study evaluating combined oral contraceptive and DepoProvera for Tubal Patency. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTubal Patency
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 23, 2014
Enrollment StartMay 1, 2014
Primary CompletionJan 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.1 years ago

Interventions

combined oral contraceptivedrug

combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption

DepoProveradrug

injectable hormonal contraceptive