Ovulation Induction With Clomiphene Citrate and Dexamethasone

Phase 4

• Conditions: Infertility
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT01856062
• Lead Sponsor: San Antonio Military Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-03-19
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-17
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clomiphene plus placebo	Placebo	A placebo of dexamethasone will be given with clomiphene citrate
Clomiphene plus dexamethasone	Dexamethasone	Oral dexamethasone will be added to clomiphene citrate

Primary Outcome Measures

Name	Time	Method
Pregnancy	12 weeks	Determined by serum hCG measurement

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy	12 weeks	Determined by ultrasound

Trial Locations

Locations (1)

San Antonio Military Medical Center; 🇺🇸 Ft. Sam Houston, Texas, United States