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

Primary Purpose

Ovulatory Dysfunction, Anovulation, Ovulation Induction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
clomiphene citrate
clomiphene citrate
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovulatory Dysfunction focused on measuring Anovulation, Ovulation induction

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Administration

Stair-Step Administration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to Ovulation With Each Protocol
We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.

Secondary Outcome Measures

Rate of Ovulation
Rate of ovulation with each dose of clomid within each protocol
Delivery Outcomes
Proportion of participants that delivered a baby based on which protocol they were randomized to.

Full Information

First Posted
November 3, 2009
Last Updated
January 5, 2018
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT01008319
Brief Title
Traditional Clomiphene Citrate Administration vs. Stair-step Approach
Acronym
Clomid
Official Title
Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovulatory Dysfunction, Anovulation, Ovulation Induction
Keywords
Anovulation, Ovulation induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Administration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stair-Step Administration
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
clomiphene citrate
Other Intervention Name(s)
Clomid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate
Other Intervention Name(s)
Clomid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Ovulation With Each Protocol
Description
We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rate of Ovulation
Description
Rate of ovulation with each dose of clomid within each protocol
Time Frame
5 years
Title
Delivery Outcomes
Description
Proportion of participants that delivered a baby based on which protocol they were randomized to.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LaTasha Craig, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States

12. IPD Sharing Statement

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Traditional Clomiphene Citrate Administration vs. Stair-step Approach

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