Traditional Clomiphene Citrate Administration vs. Stair-step Approach

Completed · Phase 3

Conditions studied: Ovulatory Dysfunction, Anovulation, Ovulation Induction

In brief

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.

Key facts

Study ID

NCT01008319

Run by

University of Oklahoma

People needed

120

Starts

2009-10-01

Expected to finish

2015-11-01

Last updated by the study team

2018-01-08

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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