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

Vaginosis, Bacterial research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Vaginosis, Bacterial

Infertility

Miscarriage

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MetronidazoleMetronidazole 500mg orally twice daily for seven days

Drug:PlaceboPlacebo will be administered orally twice daily for seven days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MetronidazolePatients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.

PlaceboPatients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm

Study Status

Terminated

Start Date: February 2011

Completed Date: June 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Biochemical Pregnancy Rate (Positive Pregnancy Test)

Secondary Outcome: Pregnancy Rate (Pregnancy Visible on Ultrasound)

Study sponsors, principal investigator, and references

Principal Investigator: Ruth Bunker Lathi

Lead Sponsor: Stanford University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01322971

American College of Obstetricians and Gynecologists. ACOG Practice Bulletin. Assessment of risk factors for preterm birth. Clinical management guidelines for obstetrician-gynecologists. Number 31, October 2001. (Replaces Technical Bulletin number 206, June 1995; Committee Opinion number 172, May 1996; Committee Opinion number 187, September 1997; Committee Opinion number 198, February 1998; and Committee Opinion number 251, January 2001). Obstet Gynecol. 2001 Oct;98(4):709-16.

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