HSG and Tubal Patency Study
HSG and Tubal Patency Study
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.
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.