Clinical trial NCT01008319: Traditional Clomiphene Citrate Administration vs. Stair-step Approach
Official title: Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovulatory Dysfunction
Anovulation
Ovulation Induction
Keywords: Anovulation
Ovulation induction
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-11-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Time to Ovulation With Each Protocol
timeFrame: 5 years
Secondary outcomes:
measure: Rate of Ovulation
timeFrame: 5 years
measure: Delivery Outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: LaTasha Craig, MD
role: PRINCIPAL_INVESTIGATOR
References: