Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population
Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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.