Suspended

Ovulation Induction With Clomiphene Citrate and Dexamethasone

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Placebo

+ Dexamethasone

Drug
Who is being recruted

Urogenital Diseases

+ Genital Diseases

+ Infertility

From 18 to 40 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorSan Antonio Military Medical Center
Study ContactBrandy M Butler, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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 TitleOvulation Induction With Clomiphene Citrate and Dexamethasone
NCT01856062
Principal SponsorSan Antonio Military Medical Center
Study ContactBrandy M Butler, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesInfertility

Criteria

3 inclusion criteria required to participate
Active duty military members or dependents seeking infertility treatment at Brooke Army Medical Center

primary or secondary infertility

candidate for intrauterine insemination (IUI)

11 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
A placebo of dexamethasone will be given with clomiphene citrate

Group II

Experimental
Oral dexamethasone will be added to clomiphene citrate

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

San Antonio Military Medical Center

Fort Sam Houston, United StatesOpen San Antonio Military Medical Center in Google Maps
SuspendedOne Study Center