Traditional Clomiphene Citrate Administration vs. Stair-step Approach

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Sodium Citrate; Zuclomiphene

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.