Clindamycin and a live biotherapeutic for improving IVF outcomes in women with abnormal vaginal microbiota
A Double-blind, Placebo-controlled Multicenter Trial on the Effect of Clindamycin and a Live Biotherapeutic on the Reproductive Outcomes of IVF Patients With Abnormal Vaginal Microbiota
This study is testing if using clindamycin alone or with a special probiotic can help women with abnormal vaginal bacteria have better success with IVF.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 333 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | Regionshospitalet Viborg, Skive Academic / other |
| Locations | 4 sites (Copenhagen and 3 other locations) |
| Trial ID | NCT05166746 on ClinicalTrials.gov |
What this trial studies
This study investigates whether the use of clindamycin, either alone or in combination with a live biotherapeutic, can enhance reproductive outcomes for IVF patients suffering from abnormal vaginal microbiota. The hypothesis is that addressing reproductive tract pathogens and restoring beneficial Lactobacillus bacteria will lead to improved clinical pregnancy rates. Participants will be screened for eligibility based on specific criteria, including their microbiota status and IVF cycle stage. The study aims to provide insights into the relationship between vaginal microbiota and fertility.
Who should consider this trial
Good fit: Ideal candidates for this study are women undergoing their first, second, or third IVF cycle who have been diagnosed with abnormal vaginal microbiota.
Not a fit: Patients with known hypersensitivity to clindamycin or severe concomitant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pregnancy rates for IVF patients with abnormal vaginal microbiota.
How similar studies have performed: Previous pilot studies have shown promising results in addressing abnormal vaginal microbiota in relation to fertility, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Abnormal vaginal microbiota. * The screening swab should be repeated if more than 3 months old. * HIV, Hepatitis B or C positivity. * First, second or third IVF stimulation cycle or embryo transfer therefrom. * BMI\<35 * Written informed consent. Exclusion Criteria: * Known or suspected hypersensitivity to clindamycin. * HPV CIN 2 or higher. * Former or current inflammatory bowel disease * Severe concomitant disease, including diabetes. * MAX 2 embryos may be transferred * Artificial heart valve * Intrauterine malformations with operation indication as determined by treating physician (Polyps, Septum, fibroma)
Where this trial is running
Copenhagen and 3 other locations
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Stork Fertility Clinic VivaNeo — Copenhagen, Denmark (Recruiting)
- Hvidovre Hospital, The Fertility Clinic — Hvidovre, Denmark (Recruiting)
- Fertility Clinic Skive, Skive Regional Hospital — Skive, Denmark (Recruiting)
Study contacts
- Study coordinator: Thor Haahr, MD
- Email: thohaa@rm.dk
- Phone: +4527885402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.