Ovulation Induction With Clomiphene Citrate and Dexamethasone

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.

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