TerminatedPhase 3ACTRN12612000065897

The use of a probiotic to treat bacterial vaginosis and augment IVF pregnancy rates.

A randomised placebo controlled study comparing the use of a one month course of an oral probiotic therapy post tinidazole antibiotic treatment on the medium term (1 month) cure rate of bacterial vaginosis in a cohort of infertile women undergoing a frozen-thawed embryo transfer with documented evidence of bacterial vaginosis at trial entry.


Sponsor

University of South Australia

Enrollment

70 participants

Start Date

Mar 5, 2012

Study Type

Interventional

Conditions

Summary

Bacterial Vaginosis (BV) is very common clinical condition with prevalence rates between 10 and 30 % of women in the reproductive age group. While in some cases BV is asymptomatic, in many women BV produces annoying symptoms (vaginal discharge, offensive smell). BV may also interfer with successful implantation of an embryo during IVF treatment, as these bacteria may be introduced from the vagina into the uterus at the time of the embryo transfer, causing inflammation of the uterine lining (endometrium). BV has been linked with a reduction in implantation rates in IVF and an increase risk of miscarriage. Therefore effective long term treatment/ prevention of BV in an IVF setting is important. The aim of this study is to determine if the oral administration of a probiotic can result in vaginal colonization and a subsequent reduction in reoccurance of BV infection after antibiotic (tinidazole) treatment.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This trial investigates whether a probiotic supplement can treat bacterial vaginosis (a common vaginal infection) and improve pregnancy rates in women aged 18 to 40 undergoing IVF with frozen embryo transfer. The study combines standard antibiotic treatment with a probiotic to see if it enhances outcomes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Women identified to have bacterial vaginosis will be administered a single 2 gm oral dose of the antibiotic Tinidazole, followed by a 4 week course of oral probiotic (2 capsules daily- total dose 4.6

Women identified to have bacterial vaginosis will be administered a single 2 gm oral dose of the antibiotic Tinidazole, followed by a 4 week course of oral probiotic (2 capsules daily- total dose 4.6 Billion organisms Lactobacillus per day).


Locations(1)

Australia

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ACTRN12612000065897