Infertility
Conditions
Keywords
ovulation induction, dexamethasone
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.
Interventions
DRUGPlacebo
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
DRUGDexamethasone
Oral dexamethasone will be added to a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction
Sponsors
San Antonio Military Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 12 weeks | Determined by serum hCG measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 12 weeks | Determined by ultrasound |
Countries
United States
Contacts
Primary ContactBrandy M Butler, MD
Backup ContactJamie Massie, MD
Outcome results
None listed