Traditional Clomiphene Citrate Administration vs. Stair-step Approach

Condition(s) targeted: Ovulatory Dysfunction; Anovulation; Ovulation Induction

Intervention: clomiphene citrate (Drug); clomiphene citrate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Oklahoma

Official(s) and/or principal investigator(s):
LaTasha Craig, MD, Principal Investigator, Affiliation: University of Oklahoma

Overall contact:
Michelle Rodriguez, RN, Phone: 405-271-1616

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.

Official title: Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to ovulation with each protocol

Secondary outcome:

Time to pregnancy with each protocol

Rate of ovulation with each dose of clomid within each protocol

Delivery, newborn (within 30 days of birth), and at 1 year of life outcomes

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Michelle Rodriguez, RN, Phone: 405-271-1616

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73013, United States; Recruiting

Starting date: October 2009
Last updated: December 2, 2014