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Trial record 43 of 55 for:    "Vaginitis" | "Metronidazole"

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

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ClinicalTrials.gov Identifier: NCT01322971
Recruitment Status : Terminated (Disease prevalence lower than expected in population.)
First Posted : March 25, 2011
Results First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ruth Bunker Lathi, Stanford University

Tracking Information
First Submitted Date  ICMJE March 23, 2011
First Posted Date  ICMJE March 25, 2011
Results First Submitted Date  ICMJE October 26, 2016
Results First Posted Date  ICMJE January 20, 2017
Last Update Posted Date January 20, 2017
Study Start Date  ICMJE February 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
Biochemical Pregnancy Rate (Positive Pregnancy Test) [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT01322971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • Pregnancy Rate (Pregnancy Visible on Ultrasound) [ Time Frame: 2 years ]
  • Miscarriage Rate (Loss of a Clinically Recognized Pregnancy) [ Time Frame: 2 years ]
  • Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis) [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population
Official Title  ICMJE Pregnancy Outcomes Following Preconception Treatment of Asymptomatic Bacterial Vaginosis in an Infertility Population: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Vaginosis, Bacterial
  • Infertility
  • Miscarriage
Intervention  ICMJE
  • Drug: Metronidazole
    Metronidazole 500mg orally twice daily for seven days
  • Drug: Placebo
    Placebo will be administered orally twice daily for seven days
Study Arms  ICMJE
  • Active Comparator: Metronidazole
    Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
    Intervention: Drug: Metronidazole
  • Placebo Comparator: Placebo
    Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 23, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2011)
1760
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01322971
Other Study ID Numbers  ICMJE SU-03212011-7604
IRB Protocol Number 20103 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ruth Bunker Lathi, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruth Bunker Lathi Stanford University
PRS Account Stanford University
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP