Traditional Clomiphene Citrate Administration vs. Stair-step Approach

NCT01008319 | Completed Phase 3 Results DMC

• 1 other identifier: 2078
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovulatory Dysfunction; Anovulation; Ovulation Induction

Keywords

Anovulation; Ovulation induction

Outcome Measures

Primary Outcomes (1)

• Time to Ovulation With Each Protocol

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

  5 years

Secondary Outcomes (2)

• Rate of Ovulation

  5 years

• Delivery Outcomes

  5 years

Study Arms (2)

Traditional Administration

ACTIVE COMPARATOR

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

Stair-Step Administration

EXPERIMENTAL

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

Interventions

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.

Also known as: Clomid

Traditional Administration

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73013, United States

Location

MeSH Terms

Conditions

Anovulation

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: LaTasha Craig, MD
• Organization: University of Oklahoma

latasha-craig@ouhsc.edu

405-271-8787

Study Officials

• LaTasha Craig, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 5, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 8, 2018
• Results First Posted: January 8, 2018

Record last verified: 2018-01

Locations

US (1)