Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population
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| ClinicalTrials.gov Identifier: NCT01322971 |
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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
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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.
| Condition or disease | Intervention/treatment | Phase |
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| Vaginosis, Bacterial Infertility Miscarriage | Drug: Metronidazole Drug: Placebo | Not Applicable |
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:
- 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.
- 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.
- 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.
- All randomized patients will continue with routine monitoring and insemination as planned by their treating physician.
- 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.
- Primary and secondary outcomes will be followed for 2 years after date of enrollment for all patients.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (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. |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | June 2012 |
| Actual Study Completion Date : | June 2012 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Metronidazole
Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.
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Drug: Metronidazole
Metronidazole 500mg orally twice daily for seven days |
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Placebo Comparator: Placebo
Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm
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Drug: Placebo
Placebo will be administered orally twice daily for seven days |
- 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
- 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 ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322971
| United States, California | |
| Ruth Lathi | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Ruth Bunker Lathi | Stanford University |
Publications:
| Responsible Party: | Ruth Bunker Lathi, Principal Investigator, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01322971 History of Changes |
| Other Study ID Numbers: |
SU-03212011-7604 IRB Protocol Number 20103 ( Other Identifier: Stanford IRB ) |
| First Posted: | March 25, 2011 Key Record Dates |
| Results First Posted: | January 20, 2017 |
| Last Update Posted: | January 20, 2017 |
| Last Verified: | November 2016 |
Keywords provided by Ruth Bunker Lathi, Stanford University:
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Bacterial Vaginosis Infertility Miscarriage Metronidazole |
Additional relevant MeSH terms:
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Infertility Vaginal Diseases Vaginosis, Bacterial Abortion, Spontaneous Genital Diseases, Male Genital Diseases, Female Bacterial Infections |
Vaginitis Pregnancy Complications Metronidazole Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents |