Traditional Clomiphene Citrate Administration vs. Stair-step Approach

Last updated: January 5, 2018
Sponsor: University of Oklahoma
Overall Status: Completed

Phase

3

Condition

Infertility

Female Hormonal Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT01008319
2078
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 > 35days.

  • 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

Exclusion Criteria:

  • Failure to spontaneously menstruate or to menstruate following progestinadministration

  • Allergy or intolerance to the side effects of clomiphene citrate, hCG (human chorionicgonadotropins), or medroxyprogesterone acetate (Provera).

  • Known anatomical defect affecting the uterine cavity including submucosal fibroids orendometrial 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 byTransvaginal ultrasound or a cycle-day-3 serum FSH of > 10 uIU/ml.

  • Positive HIV in either the female patient or her partner.

Study Design

Total Participants: 120
Study Start date:
October 01, 2009
Estimated Completion Date:
November 30, 2015

Study 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.

Connect with a study center

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73013
    United States

    Site Not Available

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