Ovulation Induction With Clomiphene Citrate and Dexamethasone

The purpose of this study is to determine if the addition of dexamethasone to clomiphene citrate will increase the pregnancy rate of intrauterine insemination (IUI) cycles.

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Drug: Dexamethasone; Drug: Placebo

Detailed Description

For decades clomiphene citrate (CC) has been the first line therapy for ovulation induction in anovulatory or oligoovulatory women, and for superovulation in women with unexplained infertility or partners with mild sperm abnormalities. While approximately 80% of patients achieve ovulation with CC, less than half conceive. Pregnancy is achieved in approximately 10% of ovulatory cycles.

Addition of dexamethasone to CC has been shown to result in pregnancy rates of 21-40% in CC-resistant women (defined as patients failing to ovulate on CC alone). A subsequent randomized controlled trial demonstrated higher pregnancy rates in patients with unexplained infertility undergoing intrauterine insemination (IUI) with CC + dexamethasone compared to those taking CC alone.

In light of the relatively high pregnancy rates achieved in previous trials, we hypothesize that dexamethasone as an adjunct to CC will increase the ovulation rate and pregnancy rate for all appropriate candidates for IU with a standard CC regimen.

Our study is designed to randomize patients undergoing ovulation induction with IUI into two groups: one consisting of a standard CC regimen, and the other consisting of the same CC regimen with the addition of daily dexamethasone. The primary outcome measure is pregnancy.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brandy M Butler, MD; Phone Number: 210-916-2168; Email: brandy.m.butler2.mil@mail.mil
• Study Contact Backup: Name: Jamie Massie, MD; Phone Number: 210-916-5335; Email: jamie.a.massie2.mil@mail.mil

Study Locations

• United States
  • Texas
    • Ft. Sam Houston, Texas, United States, 78234
      • Recruiting
      • San Antonio Military Medical Center
      • Contact: Jay R Bucci, MD; Phone Number: 210-916-2598; Email: jay.r.bucci.mil@mail.mil
      • Principal Investigator: Jamie Massie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Active duty military members or dependents seeking infertility treatment at Brooke Army Medical Center
• primary or secondary infertility
• candidate for intrauterine insemination (IUI)

Exclusion Criteria:

• Severe male factor infertility (total motile sperm count <10 million/mL)
• Bilateral fallopian tube obstruction
• Diminished ovarian reserve (baseline follicle stimulating hormone > 20)
• History of clomiphene resistance as determined by a Clomid challenge test or prior non-ovulatory cycles while taking clomiphene
• Known or suspected hypopituitarism or hypothalamic amenorrhea
• Six or more prior therapeutic CC cycles without a pregnancy
• Diabetes
• Renal impairment, hepatitis, hepatic cirrhosis, or myasthenia gravis
• Osteoporosis
• Cataracts or glaucoma
• Congenital Adrenal Hyperplasia, Cushing's disease, or any condition requiring chronic corticosteroid use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clomiphene plus dexamethasone; Oral dexamethasone will be added to clomiphene citrate	Drug: Dexamethasone; Oral dexamethasone will be added to a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction
Placebo Comparator: Clomiphene plus placebo; A placebo of dexamethasone will be given with clomiphene citrate	Drug: Placebo; A placebo with similar appearance to dexamethasone will be given with a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction; Other Names: sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Determined by serum hCG measurement	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy	Determined by ultrasound	12 weeks

Collaborators and Investigators

• Sponsor: San Antonio Military Medical Center
• Investigators: Principal Investigator: Jamie Massie, MD, San Antonio Military Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: dexamethasone; ovulation induction
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 379303-1