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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by Stanford University
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01322971
First received: March 23, 2011
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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
Infertility
Miscarriage
Drug: Metronidazole
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy Rate (Pregnancy Visible on Ultrasound) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Miscarriage Rate (Loss of a Clinically Recognized Pregnancy) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1760
Study Start Date: February 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (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 hydroixde 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  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 ClinicalTrials.gov identifier: NCT01322971

Contacts
Contact: Jamie Massie, MD (650) 498-7408 jamiem1@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jamie Massie, MD    650-498-7408    jamiem1@stanford.edu   
Principal Investigator: Ruth Bunker Lathi         
Sub-Investigator: Florette Kimberly Gray Hazard MD         
Sub-Investigator: Natali Aziz MD         
Sub-Investigator: Jamie Massie         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ruth Bunker Lathi Stanford University
  More Information

Publications:

Responsible Party: Ruth Bunker Lathi, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01322971     History of Changes
Other Study ID Numbers: SU-03212011-7604, IRB Protocol Number 20103
Study First Received: March 23, 2011
Last Updated: March 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Bacterial Vaginosis
Infertility
Miscarriage
Metronidazole

Additional relevant MeSH terms:
Infertility
Abortion, Spontaneous
Bacterial Infections
Vaginosis, Bacterial
Pregnancy Complications
Genital Diseases, Male
Genital Diseases, Female
Vaginitis
Vaginal Diseases
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014