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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
151 participants were screened ; 2 were randomized

Reporting Groups
  Description
Metronidazole

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

Placebo

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


Participant Flow:   Overall Study
    Metronidazole   Placebo
STARTED   1   1 
COMPLETED   0   0 
NOT COMPLETED   1   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metronidazole

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

Placebo

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 Total of all reporting groups

Baseline Measures
   Metronidazole   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Median (Standard Deviation)
 37  (0)   37  (0)   37  (0) 
Gender 
[Units: Participants]
Count of Participants
     
Female      1 100.0%      1 100.0%      2 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1   1   2 


  Outcome Measures

1.  Primary:   Biochemical Pregnancy Rate (Positive Pregnancy Test)   [ Time Frame: up to 2 years ]

2.  Secondary:   Pregnancy Rate (Pregnancy Visible on Ultrasound)   [ Time Frame: up to 2 years ]

3.  Secondary:   Miscarriage Rate (Loss of a Clinically Recognized Pregnancy)   [ Time Frame: up to 2 years ]

4.  Secondary:   Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)   [ Time Frame: up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
151 screened 2 were randomized both refused to take medication not knowing if it were placebo or drug


  More Information

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
e-mail: rlathi@stanford.edu


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