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NCT01322971 · ClinicalTrials.gov registry record · NA
Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT01322971: Clinical Trial NA study, sponsored by Stanford University.
NCT01322971 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01322971, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
Bacterial vaginosis (BV) is a common vaginal infection characterized by a pathologic shift in the normal vaginal flora. BV has been associated with a number of poor reproductive outcomes, including infertility, preterm labor and premature rupture of membranes. If BV does disrupt normal embryologic development, then the treatment of BV prior to conception may improve implantation rates and other pregnancy outcomes in the infertile population. This is a prospective, randomized, double-blind, placebo-controlled trial in which infertile women undergoing intrauterine insemination or embryo transfer are screened for BV prior to treatment. Those patients who screen positive for BV will then be randomized into the treatment arm(metronidazole 500mg by mouth twice daily for 7 days) or the control arm (placebo by mouth twice daily for 7 days). The primary outcome, positive pregnancy test rate (i.e. biochemical pregnancy rate), will then be assessed. Secondary outcomes, such as clinical pregnancy rate, miscarriage rate, and live birth rate will also be examined.
Interventions
- DRUG Placebo
- DRUG Metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01322971
The ClinicalTrials.gov registry entry for NCT01322971 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01322971 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01322971 about?
NCT01322971 is a clinical study titled "Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population". Bacterial vaginosis (BV) is a common vaginal infection characterized by a pathologic shift in the normal vaginal flora. BV has been associated with a number of poor reproductive outcomes, including infertility, preterm labor and premature rupture of membranes. If BV does disrupt normal embryologic d...
What is the current status of trial NCT01322971?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2011-02. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01322971?
The interventions under investigation include: Placebo (DRUG), Metronidazole (DRUG).
Who is sponsoring clinical trial NCT01322971?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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