Ovulation Induction With Clomiphene Citrate and Dexamethasone
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|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
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Placebo Drug: Dexamethasone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Experimental: Clomiphene plus dexamethasone
Oral dexamethasone will be added to clomiphene citrate
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
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
- Pregnancy [ Time Frame: 12 weeks ]Determined by serum hCG measurement
- Clinical pregnancy [ Time Frame: 12 weeks ]Determined by ultrasound
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
|Contact: Brandy M Butler, MDfirstname.lastname@example.org|
|Contact: Jamie Massie, MDemail@example.com|
|United States, Texas|
|San Antonio Military Medical Center||Recruiting|
|Ft. Sam Houston, Texas, United States, 78234|
|Contact: Jay R Bucci, MD 210-916-2598 firstname.lastname@example.org|
|Principal Investigator: Jamie Massie, MD|
|Principal Investigator:||Jamie Massie, MD||San Antonio Military Medical Center|