Ovulation Induction With Clomiphene Citrate and Dexamethasone
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 28, 2014
February 1, 2014
2.1 years
March 19, 2013
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy
Determined by serum hCG measurement
12 weeks
Secondary Outcomes (1)
Clinical pregnancy
12 weeks
Study Arms (2)
Clomiphene plus dexamethasone
EXPERIMENTALOral dexamethasone will be added to clomiphene citrate
Clomiphene plus placebo
PLACEBO COMPARATORA placebo of dexamethasone will be given with clomiphene citrate
Interventions
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
Oral dexamethasone will be added to a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction
Eligibility Criteria
You may qualify if:
- Active duty military members or dependents seeking infertility treatment at Brooke Army Medical Center
- primary or secondary infertility
- candidate for intrauterine insemination (IUI)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Massie, MD
San Antonio Military Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Reproductive Endocrinologist
Study Record Dates
First Submitted
March 19, 2013
First Posted
May 17, 2013
Study Start
May 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 28, 2014
Record last verified: 2014-02