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

December 10, 2021 updated by: Ruth Bunker Lathi, Stanford University

Pregnancy Outcomes Following Preconception Treatment of Asymptomatic Bacterial Vaginosis in an Infertility Population: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Ruth Lathi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy Rate (Pregnancy Visible on Ultrasound)
Time Frame: up to 2 years
up to 2 years
Miscarriage Rate (Loss of a Clinically Recognized Pregnancy)
Time Frame: up to 2 years
up to 2 years
Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Ruth Bunker Lathi, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (Estimate)

March 25, 2011

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-03212011-7604
  • IRB Protocol Number 20103 (Other Identifier: Stanford IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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