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

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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

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.


Condition or disease Intervention/treatment Phase
Ovulatory Dysfunction Anovulation Ovulation Induction Drug: clomiphene citrate Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial
Study Start Date : October 2009
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008319


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73013
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: LaTasha Craig, MD University of Oklahoma

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01008319     History of Changes
Other Study ID Numbers: 2078
First Posted: November 5, 2009    Key Record Dates
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by University of Oklahoma:
Anovulation
Ovulation induction

Additional relevant MeSH terms:
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Anovulation
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators