Trial Outcomes & Findings for Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population (NCT NCT01322971)

Results Overview

Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

up to 2 years

Results posted on

2021-12-20

Participant Flow

151 participants were screened ; 2 were randomized

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metronidazole n=1 Participants 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 n=1 Participants 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 n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 0 • n=5 Participants	37 years STANDARD_DEVIATION 0 • n=7 Participants	37 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 2 years

Population: No data were collected for this outcome

Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

Population: No data were collected for this outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

Population: No data were collected for this outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

Population: No data were collected for this outcome

Outcome measures

Outcome data not reported

Adverse Events

Metronidazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ruth Lathi

Stanford University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place