Traditional Clomiphene Citrate Administration vs. Stair-step Approach (Clomid)
Ovulatory Dysfunction, Anovulation, Ovulation Induction
About this trial
This is an interventional treatment trial for Ovulatory Dysfunction focused on measuring Anovulation, Ovulation induction
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.
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Traditional Administration
Stair-Step Administration
The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.
The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.