Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stanford University
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• Women who are actively trying to conceive via intrauterine insemination or in vitro fertilization

Exclusion Criteria:

• Current use of an oral or vaginal antibiotic.

• History of allergy or adverse reaction to metronidazole.

• Prior enrollment in study (patients returning for repeat cycle may not be re-enrolled).