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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000065897

Acronym

The "ProViva" study

Enrollment

Registered

2012-01-12

Start date

2012-03-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 Billion organisms Lactobacillus per day).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

1. Presence of bacterial vaginosis infection on clinical examination and Nugent score assessment. 2. Undergoing a frozen embryo (vitrification) transfer cycle of IVF treatment

Exclusion criteria

1. Women receiving concurrent vaginal medication (progesterone, antifungal, antibiotic). 2. Allergy to Tindazole or metronidazole 3. Concurrent Candida vaginal infection 4. Women undergoing a frozen embryo transfer using "slow freeze" stored embryos. 5. Antibiotic use in the last 2 weeks 6. Prior enrolment in the ProViva Study

Outcome results