Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(Disease prevalence lower than expected in population.)
Information provided by (Responsible Party):
Ruth Bunker Lathi, Stanford University Identifier:
First received: March 23, 2011
Last updated: November 23, 2016
Last verified: November 2016

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.

Condition Intervention
Vaginosis, Bacterial
Drug: Metronidazole
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregnancy Outcomes Following Preconception Treatment of Asymptomatic Bacterial Vaginosis in an Infertility Population: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Biochemical Pregnancy Rate (Positive Pregnancy Test) [ Time Frame: up to 2 years ]
    Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metronidazole
Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
Drug: Metronidazole
Metronidazole 500mg orally twice daily for seven days
Placebo Comparator: Placebo
Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
Drug: Placebo
Placebo will be administered orally twice daily for seven days

Detailed Description:

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:

  1. Patients will be notified of study via face-to-face contact at the initial clinic visit (baseline ultrasound visit, menstrual cycle day 2-5), by physician referral or the Stanford website. Patients expressing interest will be screened in person to confirm that they meet all enrollment criteria. The participant will be asked to sign informed consent documents and a brief intake questionnaire with then be administered.
  2. Enrolled patients will then be screened for bacterial vaginosis at their next visit (typically on menstrual cycle day 12), prior to transvaginal ultrasound. The screening will require that a speculum be inserted into the vagina and a vaginal smear be collected with a swab from the posterior fornix. A microscopic slide will be prepared by rolling the swab on the surface of a glass slide. The diagnosis of bacterial vaginosis will be established clinically using the Amsel criteria to confirm 3 of the following 4 signs: clue cells; vaginal pH ≥4.5; fishy odor before or after the addition of 10% potassium hydroxide solution to a wet-mount side; and a homogeneous, off-white, discharge. For validation of clinical diagnosis, 100% of screen positive slides, and 10% of screen negative slides, will be sent for to the Department of Pathology for Gram staining.
  3. The patients with a positive screen for bacterial vaginosis will then be randomized to receive metronidazole 500mg orally twice daily for seven days (treatment arm) or placebo orally twice daily for seven days(control arm). Randomization will be performed using a computer-generated code. Those patients whose screen is negative will also be followed for outcomes, but no randomization will be performed.
  4. All randomized patients will continue with routine monitoring and insemination as planned by their treating physician.
  5. If pregnancy is confirmed at least 12 weeks after intrauterine insemination by ultrasound evidence of a fetus with heartbeat, information will then be collected regarding the pregnancy and its outcome.
  6. Primary and secondary outcomes will be followed for 2 years after date of enrollment for all patients.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01322971

United States, California
Ruth Lathi
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Ruth Bunker Lathi Stanford University
  More Information


Responsible Party: Ruth Bunker Lathi, Principal Investigator, Stanford University Identifier: NCT01322971     History of Changes
Other Study ID Numbers: SU-03212011-7604
IRB Protocol Number 20103 ( Other Identifier: Stanford IRB )
Study First Received: March 23, 2011
Results First Received: October 26, 2016
Last Updated: November 23, 2016

Keywords provided by Stanford University:
Bacterial Vaginosis

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Abortion, Spontaneous
Genital Diseases, Male
Genital Diseases, Female
Bacterial Infections
Pregnancy Complications
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on April 26, 2017