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Ovulation Induction With Clomiphene Citrate and Dexamethasone

Information source: San Antonio Military Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Placebo (Drug); Dexamethasone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: San Antonio Military Medical Center

Official(s) and/or principal investigator(s):
Jamie Massie, MD, Principal Investigator, Affiliation: San Antonio Military Medical Center

Overall contact:
Brandy M Butler, MD, Phone: 210-916-2168, Email: brandy.m.butler2.mil@mail.mil


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.

Clinical Details

Official title: Ovulation Induction With Clomiphene Citrate and Dexamethasone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Pregnancy

Secondary outcome: Clinical pregnancy

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.


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.


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

Locations and Contacts

Brandy M Butler, MD, Phone: 210-916-2168, Email: brandy.m.butler2.mil@mail.mil

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

Starting date: May 2013
Last updated: February 27, 2014

Page last updated: August 23, 2015

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