Clinical trial: HSG and Tubal Patency Study (NCT02146248)

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.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 0