Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Traditional Clomiphene Citrate Administration vs. Stair-step Approach (Clomid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008319
Recruitment Status : Completed
First Posted : November 5, 2009
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE November 3, 2009
First Posted Date  ICMJE November 5, 2009
Results First Submitted Date  ICMJE March 29, 2017
Results First Posted Date  ICMJE January 8, 2018
Last Update Posted Date January 8, 2018
Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
Time to ovulation with each protocol [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • Rate of Ovulation [ Time Frame: 5 years ]
    Rate of ovulation with each dose of clomid within each protocol
  • Delivery Outcomes [ Time Frame: 5 years ]
    Proportion of participants that delivered a baby based on which protocol they were randomized to.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
  • Time to pregnancy with each protocol [ Time Frame: 2 years ]
  • Rate of ovulation with each dose of clomid within each protocol [ Time Frame: 2 years ]
  • Delivery, newborn (within 30 days of birth), and at 1 year of life outcomes [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Traditional Clomiphene Citrate Administration vs. Stair-step Approach
Official Title  ICMJE Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovulatory Dysfunction
  • Anovulation
  • Ovulation Induction
Intervention  ICMJE
  • Drug: clomiphene citrate
    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 Name: Clomid
  • Drug: clomiphene citrate
    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, a blood draw (to test progesterone level) will be done. Increased dose of clomiphene citrate for 5 days starting that day. A repeat transvaginal ultrasound in one week to determine if there is a dominant follicle. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present.
    Other Name: Clomid
Study Arms  ICMJE
  • Active Comparator: Traditional Administration
    The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.
    Intervention: Drug: clomiphene citrate
  • Experimental: Stair-Step Administration
    The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
    Intervention: Drug: clomiphene citrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2009)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008319
Other Study ID Numbers  ICMJE 2078
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: LaTasha Craig, MD University of Oklahoma
PRS Account University of Oklahoma
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP