Clinical trial NCT02146248: HSG and Tubal Patency Study
Official title: Tubal Patency During the Menstrual Cycle and During Treatment With Hormonal Contraceptives: a Pilot Study in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tubal Patency
Keywords: hysterosalpingography, DMPA, combined oral contraceptive, tubal patency
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2014-05-23
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

i. Women between 18 and 40 years old ii. In good health, with regular menstrual cycles that occur 24 - 37 days iii. No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment.

iv. Have a negative urine pregnancy test at the admission visit. v. Have a negative chlamydia test at the admission visit. vi. Not be at risk for pregnancy. They will be consistently using a non-hormonal contraception method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the screening visit through the first study cycle. After starting the combined OC (see Visit 4 below), use of a non-hormonal method is no longer required.

vii. In the opinion of the investigator, willing and able to follow all study requirements, including use of the approved study medications (doxycycline, oral contraceptive and DMPA).

viii. Understand and sign an IRB approved inform consent form prior to screening activities.

ix. Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤145 mm Hg after 5 minutes in sitting position.

x. Agree not to participate in any other clinical trials during the course of this study.

Exclusion Criteria:

* i. Women with menstrual cycle length of less than 24 or more than 37 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days ii. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test iii. Women planning pregnancy within their months of study participation iv. Currently breast-feeding or within 30 days of discontinuing breast feeding v. Current use of a hormonal IUD, or other hormonal contraception (including oral contraceptives, contraceptive vaginal rings, contraceptive patches, or contraceptive implants) within 30 days prior to screening. NOTE: Discontinuation of hormonal contraception or removal of implanted hormonal contraceptives must have been for personal reasons unrelated to the purpose of enrollment in this study.

vi. Undiagnosed abnormal genital bleeding vii. Known hypersensitivity to radio-opaque contrast, doxycycline, levonorgestrel, ethinyl estradiol or depo-medroxyprogesterone acetate. The active ingredients in the approved medications used in the study.

viii. Anomalies in the clinical exam or history done at screening visit recognized as clinically significant by the investigator.

ix. Unable to pass a uterine sound at the screening examination. x. A positive test for chlamydia at screening, or a history of a positive test within the last 6 months.

xi. A clinically significant Pap test abnormality, as managed by current local or national guidelines that would require treatment over the next 6 months.

xii. Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer) xiii. Body mass index (BMI) \>35. xiv. Current use of a non-hormone containing (copper) intrauterine device (IUD). NOTE: Removal of an IUD must have been for personal reasons unrelated to the purpose of enrollment in this study.

xv. Smoking if \> age 35. xvi. Personal history of venous or arterial thrombosis or embolism, or family history in a first-degree relative \<55 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk.

xvii. Cerebrovascular or cardiovascular disease. xviii. History of retinal vascular lesions, unexplained partial or complete loss of vision.

xix. Headaches with focal neurological symptoms. xx. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.

xxi. Use of liver enzyme inducers on a regular basis. xxii. History of involuntary infertility, pelvic inflammatory disease (not followed by a normal pregnancy), or known gynecologic conditions or surgery that could affect tubal patency (e.g. tubal adhesions, endometriosis, hydrosalpinx, salpingectomy, hysterectomy, oophorectomy).

xxiii. History of a prior HSG showing tubal occlusion on one or both sides.

Primary outcomes:
measure: Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular
timeFrame: follicular phase HSG
measure: Number of Participants With Bilateral Tubal Patency as Assessed by HSG - Luteal
timeFrame: luteal phase HSG
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Bilateral Tubal Patency as Assessed by HSG - OC HSG
timeFrame: HSG on OC
measure: Number of Participants With Bilateral Tubal Patency as Assessed by HSG - DMPA HSG
timeFrame: HSG on DMPA
measure: Number of Participants With Bilateral Tubal Patency as Assessed by HSG -- Post DMPA Add Back COC HSG
timeFrame: HSG on OC after DMPA
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jeffrey Jensen, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: