Traditional Clomiphene Citrate Administration vs. Stair-step Approach

Anovulation Clinical Trial

— Clomid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008319
• Other study ID #: 2078
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2009
• Last updated: January 5, 2018
• Start date: October 2009
• Est. completion date: November 2015

Study information

• Verified date: January 2018
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anovulation
• Ovulation Induction
• Ovulatory Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Ovulation With Each Protocol	We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.	5 years
Secondary	Rate of Ovulation	Rate of ovulation with each dose of clomid within each protocol	5 years
Secondary	Delivery Outcomes	Proportion of participants that delivered a baby based on which protocol they were randomized to.	5 years