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

Phase 3

• Conditions: bacterial vaginosis; infertility; In Vitro Fertilisation (IVF); Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12612000065897
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure of bacterial vaginosis as assessed by established clinical (Amsel) and laboratory (Nugent score) criteria.[Examination at the time of the embryo transfer, approximately 4 weeks after administration of the Tinidazole antibiotic and commencement of probiotic or placebo capsules.]

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy rate (proportion of embryo transferes resulting in a positive serum bHCG result)[2 weeks after embryo transfer];Viable clinical pregnancy rate (proportion of transfered embryos that result in a viable fetal heart pulsation on ultrasound scan).[7-8 weeks gestation];miscarriage rate[assessed at time of first trimeter ultrasound (7-8 weeks gestation)];Concentration of bacterial vaginosis related endotoxins washed off the surface of the embryo transfer catheter after completion of the embryo transfer. Endotoxin will be quantified by the Endosafe-PTS assay system (Charles River, USA).[At the time of the embryo transfer]