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Completed

NCT Number: NCT01008319

Traditional Clomiphene Citrate Administration vs. Stair-step Approach

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clomiphene Citrate

Drug

Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present.

Other names: Clomid

Primary outcomes

  1. Time to Ovulation With Each Protocol

    Time frame: 5 years

    We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.

Secondary outcomes

  1. Rate of Ovulation

    Time frame: 5 years

    Rate of ovulation with each dose of clomid within each protocol

  2. Delivery Outcomes

    Time frame: 5 years

    Proportion of participants that delivered a baby based on which protocol they were randomized to.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: Clomid

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2009
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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