Recruiting

Clomiphene Citrate & Dexamethasone

Sponsor:

San Antonio Military Medical Center

Code:

NCT01856062

Conditions

Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Placebo

Dexamethasone

Study Details

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.

Conditions

Infertility

Study ID

NCT01856062

Start date

May, 2013

Status verified date

Feb, 2014

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clomiphene plus dexamethasone

Oral dexamethasone will be added to clomiphene citrate

placebo comparator: Clomiphene plus placebo

A placebo of dexamethasone will be given with clomiphene citrate

Interventions

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

Primary outcome measure

  • Pregnancy [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Brandy M Butler, MD

210-916-2168brandy.m.butler2.mil@mail.mil

Jamie Massie, MD

210-916-5335jamie.a.massie2.mil@mail.mil

Locations

San Antonio Military Medical Center

Recruiting

Ft. Sam Houston, Texas, United States, 78234

Contacts

Jay R Bucci, MD

210-916-2598jay.r.bucci.mil@mail.mil

Principal Investigator:

Jamie Massie, MD

More Information

Sponsor

San Antonio Military Medical Center

Last update posted

Feb 28, 2014

Last verified

Feb, 2014

Keywords

  • ovulation induction
  • dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by San Antonio Military Medical Center on 2014-02-28.