Ovulation Induction With Clomiphene Citrate and Dexamethasone
NCT ID: NCT01856062
Last Updated: 2014-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
140 participants
INTERVENTIONAL
2013-05-31
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Clomiphene plus dexamethasone
Oral dexamethasone will be added to clomiphene citrate
Dexamethasone
Oral dexamethasone will be added to a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction
Clomiphene plus placebo
A placebo of dexamethasone will be given with clomiphene citrate
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
Interventions
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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
Dexamethasone
Oral dexamethasone will be added to a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* primary or secondary infertility
* candidate for intrauterine insemination (IUI)
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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San Antonio Military Medical Center
FED
Responsible Party
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Jeremy King
Reproductive Endocrinologist
Principal Investigators
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Jamie Massie, MD
Role: PRINCIPAL_INVESTIGATOR
San Antonio Military Medical Center
Locations
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San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Jay R Bucci, MD
Role: primary
Other Identifiers
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379303-1
Identifier Type: -
Identifier Source: org_study_id