Ovulation Induction With Clomiphene Citrate and Dexamethasone

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ovulation Induction With Clomiphene Citrate and Dexamethasone

Conditions
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Infertility

Intervention / Treatment
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* Drug: Placebo
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clomiphene plus dexamethasone<br>Oral dexamethasone will be added to clomiphene citrate | Drug: Dexamethasone<br>* Oral dexamethasone will be added to a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction<br>|
| Placebo Comparator: Clomiphene plus placebo<br>A placebo of dexamethasone will be given with clomiphene citrate | Drug: Placebo<br>* 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<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Determined by serum hCG measurement | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | Determined by ultrasound | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovulation induction, dexamethasone