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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Vaginosis, Bacterial
Infertility
Miscarriage
Interventions Drug: Metronidazole
Drug: Placebo
Enrollment 2
Recruitment Details  
Pre-assignment Details 151 participants were screened ; 2 were randomized
Arm/Group Title Metronidazole Placebo
Hide Arm/Group Description

Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.

Metronidazole: Metronidazole 500mg orally twice daily for seven days

Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm

Placebo: Placebo will be administered orally twice daily for seven days

Period Title: Overall Study
Started 1 1
Completed 0 0
Not Completed 1 1
Arm/Group Title Metronidazole Placebo Total
Hide Arm/Group Description

Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.

Metronidazole: Metronidazole 500mg orally twice daily for seven days

Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm

Placebo: Placebo will be administered orally twice daily for seven days

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
37  (0) 37  (0) 37  (0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
1
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Biochemical Pregnancy Rate (Positive Pregnancy Test)
Hide Description Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome
Arm/Group Title Metronidazole Placebo
Hide Arm/Group Description:

Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.

Metronidazole: Metronidazole 500mg orally twice daily for seven days

Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm

Placebo: Placebo will be administered orally twice daily for seven days

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Pregnancy Rate (Pregnancy Visible on Ultrasound)
Hide Description [Not Specified]
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome
Arm/Group Title Metronidazole Placebo
Hide Arm/Group Description:

Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.

Metronidazole: Metronidazole 500mg orally twice daily for seven days

Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm

Placebo: Placebo will be administered orally twice daily for seven days

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Miscarriage Rate (Loss of a Clinically Recognized Pregnancy)
Hide Description [Not Specified]
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome
Arm/Group Title Metronidazole Placebo
Hide Arm/Group Description:

Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.

Metronidazole: Metronidazole 500mg orally twice daily for seven days

Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm

Placebo: Placebo will be administered orally twice daily for seven days

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)
Hide Description [Not Specified]
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome
Arm/Group Title Metronidazole Placebo
Hide Arm/Group Description:

Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.

Metronidazole: Metronidazole 500mg orally twice daily for seven days

Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm

Placebo: Placebo will be administered orally twice daily for seven days

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description All participants withdrew prior to entering any protocol specified adverse event collection period.
 
Arm/Group Title Metronidazole Placebo
Hide Arm/Group Description

Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.

Metronidazole: Metronidazole 500mg orally twice daily for seven days

Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm

Placebo: Placebo will be administered orally twice daily for seven days

All-Cause Mortality
Metronidazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Metronidazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metronidazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
151 screened 2 were randomized both refused to take medication not knowing if it were placebo or drug
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ruth Lathi
Organization: Stanford University
Publications:
Responsible Party: Ruth Bunker Lathi, 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 Submitted: March 23, 2011
First Posted: March 25, 2011
Results First Submitted: October 26, 2016
Results First Posted: January 20, 2017
Last Update Posted: January 20, 2017