An interventional study of Metronidazole and Placebo in Vaginosis, Bacterial, Infertility and Miscarriage, sponsored by Stanford University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-20.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
The purpose of this study is to determine if preconception treatment of asymptomatic bacterial vaginosis improves pregnancy outcomes (i.e. biochemical pregnancy rate). Study protocol as follows:
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 2 is below the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Drug: Metronidazole
Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Drug: Placebo
Metronidazole 500mg orally twice daily for seven days
Placebo will be administered orally twice daily for seven days
Biochemical Pregnancy Rate (Positive Pregnancy Test)
Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test
Time frame: up to 2 years
Pregnancy Rate (Pregnancy Visible on Ultrasound)
Time frame: up to 2 years
Miscarriage Rate (Loss of a Clinically Recognized Pregnancy)
Time frame: up to 2 years
Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)
Time frame: up to 2 years
| Milestone | Metronidazole | Placebo |
|---|---|---|
| Started | 1 | 1 |
| Completed | 0 | 0 |
| Not completed | 1 | 1 |
Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metronidazole | — | — | — |
| Placebo | — | — | — |
| Age, Categorical(Participants) | Metronidazole | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Metronidazole | Placebo | Total |
|---|---|---|---|
| Median | 37 ± 0 | 37 ± 0 | 37 ± 0 |
| Sex: Female, Male(Participants) | Metronidazole | Placebo | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Metronidazole | Placebo | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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