Traditional Clomiphene Citrate Administration vs. Stair-step Approach
Condition: Ovulatory Dysfunction; Anovulation; Ovulation Induction
MeSH terms: Anovulation
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The traditional administration of clomiphene citrate for ovulation induction involves taking
      clomiphene citrate for 5 days. If ovulation does not occur within 14 days, a progestin pill
      (such as Provera) is prescribed for 10 days to induce a period (which normally occurs within
      1 week of stopping the pill). Then a higher dose of clomiphene citrate will be prescribed.

      The stair-step administration of clomiphene citrate for ovulation induction also involves
      taking clomiphene citrate for 5 days. In contrast, if ovulation does not occur within 7-9
      days, a progestin pill (such as Provera) would NOT be taken to induce a period. The dose of
      clomiphene will then be increased. Therefore, this would do away with the 10 days of taking
      the progestin pill, and also do away with waiting for a period (usually 3 to 7 days) for a
      total of up to a 20 day difference between clomiphene citrate dosing cycles.
    

Intervention name(s): clomiphene citrate; clomiphene citrate
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Clomid; Clomid
Intervention MeSH terms: Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anovulation; Ovulation induction