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Ovulation Induction With Clomiphene Citrate and Dexamethasone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856062
Recruitment Status : Unknown
Verified February 2014 by Jeremy King, San Antonio Military Medical Center.
Recruitment status was:  Recruiting
First Posted : May 17, 2013
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Jeremy King, San Antonio Military Medical Center

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Placebo Drug: Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ovulation Induction With Clomiphene Citrate and Dexamethasone
Study Start Date : May 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015


Arm Intervention/treatment
Experimental: Clomiphene plus dexamethasone
Oral dexamethasone will be added to clomiphene citrate
Drug: Dexamethasone
Oral dexamethasone will be added to a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction

Placebo Comparator: Clomiphene plus placebo
A placebo of dexamethasone will be given with clomiphene citrate
Drug: 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
Other Name: sugar pill




Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 12 weeks ]
    Determined by serum hCG measurement


Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 12 weeks ]
    Determined by ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856062


Contacts
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Contact: Brandy M Butler, MD 210-916-2168 brandy.m.butler2.mil@mail.mil
Contact: Jamie Massie, MD 210-916-5335 jamie.a.massie2.mil@mail.mil

Locations
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United States, Texas
San Antonio Military Medical Center Recruiting
Ft. Sam Houston, Texas, United States, 78234
Contact: Jay R Bucci, MD    210-916-2598    jay.r.bucci.mil@mail.mil   
Principal Investigator: Jamie Massie, MD         
Sponsors and Collaborators
San Antonio Military Medical Center
Investigators
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Principal Investigator: Jamie Massie, MD San Antonio Military Medical Center

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Responsible Party: Jeremy King, Reproductive Endocrinologist, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT01856062    
Other Study ID Numbers: 379303-1
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014
Keywords provided by Jeremy King, San Antonio Military Medical Center:
ovulation induction
dexamethasone
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Dexamethasone
Dexamethasone acetate
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Estrogen Antagonists