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