Pregnancy Outcomes Following Preconception Treatment of Asymptomatic Bacterial Vaginosis in an Infertility Population: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.
| City: |
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Stanford |
| State: |
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California |
| Zip Code: |
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94305 |
| Conditions: |
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Vaginosis, Bacterial - Infertility - Miscarriage |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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).
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| NCT ID: |
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NCT01322971 |
| Primary Contact: |
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Principal Investigator
Ruth Bunker Lathi
Stanford University
Jamie Massie, MD
Phone: (650) 498-7408
Email: jamiem1@stanford.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Stanford, California 94305
United States
Jamie Massie, MD
Phone: 650-498-7408
Email: jamiem1@stanford.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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