Traditional Clomiphene Citrate Administration vs. Stair-step Approach
Condition: Ovulatory Dysfunction; Anovulation; Ovulation Induction
MeSH terms: Anovulation
Intervention: clomiphene citrate; clomiphene citrate
Intervention description: Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present.; Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, a blood draw (to test progesterone level) will be done. Increased dose of clomiphene citrate for 5 days starting that day. A repeat transvaginal ultrasound in one week to determine if there is a dominant follicle. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present.
Intervention MeSH terms: Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Anovulation; Ovulation induction

Summary:

      The purpose of this study is to compare the length of time to achieve ovulation and pregnancy
      with a traditional protocol administration of clomiphene citrate versus a stair step
      administration.

      Our hypothesis is by using a stair-step approach in which a period is not induced between
      administrations of escalating doses of clomiphene citrate, the time to ovulation and
      pregnancy may be reduced.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ovulatory dysfunction as evidenced by mid-luteal progesterone less then 3ng/dL,
             non-biphasic basal body temperature charting, or menstrual history of cycles > 35
             days.

          -  Female patients 18 to 45 years old

          -  Six months or greater of unprotected intercourse without pregnancy.

          -  Normal TSH and prolactin serum levels

          -  Semen analysis of male partner with > 15 million motile sperm on semen analysis.

               -  NOTE: Must be willing to travel to the Oklahoma City area for treatment.

        Exclusion Criteria:

          -  Failure to spontaneously menstruate or to menstruate following progestin
             administration

          -  Allergy or intolerance to the side effects of clomiphene citrate, hCG (human chorionic
             gonadotropins), or medroxyprogesterone acetate (Provera).

          -  Known anatomical defect affecting the uterine cavity including submucosal fibroids or
             endometrial polyps.

          -  Know tubal hydrosalpinx or risk factors for tubal obstruction

          -  Known liver dysfunction

          -  Known or suspected androgen secreting tumor, cushings disease, or adrenal hyperplasia
             (congenital or adult onset)

          -  Ovarian cyst > 20mm or endometrial lining >6 mm on trans-vaginal baseline ultrasound.

          -  Stage III or IV endometriosis

          -  Decreased ovarian reserve as evidenced by antral follicle count less than 6 by
             Transvaginal ultrasound or a cycle-day-3 serum FSH of > 10 uIU/ml.

          -  Positive HIV in either the female patient or her partner.