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<p>The primary aim of the present randomised, double-blind, placebo-controlled trial was to investigate whether clindamycin and live <i>Lactobacillus crispatus</i> CTV-05 (LACTIN-V) would improve clinical pregnancy rates in IVF patients with abnormal vaginal microbiota (AVM) defined by high quantitative PCR loads of <i>Fannyhessea vaginae</i> and <i>Gardnerella spp</i>. IVF patients were randomised prior to embryo transfer into three parallel groups 1:1:1. Group one (CLLA) received clindamycin 300 mg ×2 daily for 7 days followed by vaginal LACTIN-V until the day of pregnancy scan. Group two (CLPL) received clindamycin and placebo LACTIN-V, and finally, group three (PLPL) received an identical placebo of both drugs. A total of 1533 patients were screened, and 338 patients were randomised. The clinical pregnancy rates per embryo transfer were 42% (95%CI 32–52%), 46% (95%CI 36–56%) and 45% (95%CI 35–56%) in the CLLA, CLPL, PLPL groups respectively. Thus, treatment of AVM did not improve reproductive outcome. The EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) clinical trial identifier is 2016-002385-31; first registration day 2016-07-11.</p>

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Efficacy of clindamycin and LACTIN-V for in vitro fertilization patients with vaginal dysbiosis: a randomised double-blind, placebo-controlled multicentre trial

  • 期刊论文

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  • 发表日期：

    2025年6月4日

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  • Thor Haahr,
  • Nina la Cour Freiesleben,
  • Mette Brix Jensen,
  • Helle Olesen Elbaek,
  • Birgit Alsbjerg,
  • Rita Laursen,
  • Lisbeth Prætorius,
  • Henriette Svarre Nielsen,
  • Anja Pinborg,
  • Vibeke Hartvig Boujida,
  • Thomas Roland Pedersen,
  • Axel Skafte-Holm,
  • Jørgen Skov Jensen,
  • Peter Humaidan

摘要

The primary aim of the present randomised, double-blind, placebo-controlled trial was to investigate whether clindamycin and live Lactobacillus crispatus CTV-05 (LACTIN-V) would improve clinical pregnancy rates in IVF patients with abnormal vaginal microbiota (AVM) defined by high quantitative PCR loads of Fannyhessea vaginae and Gardnerella spp. IVF patients were randomised prior to embryo transfer into three parallel groups 1:1:1. Group one (CLLA) received clindamycin 300 mg ×2 daily for 7 days followed by vaginal LACTIN-V until the day of pregnancy scan. Group two (CLPL) received clindamycin and placebo LACTIN-V, and finally, group three (PLPL) received an identical placebo of both drugs. A total of 1533 patients were screened, and 338 patients were randomised. The clinical pregnancy rates per embryo transfer were 42% (95%CI 32–52%), 46% (95%CI 36–56%) and 45% (95%CI 35–56%) in the CLLA, CLPL, PLPL groups respectively. Thus, treatment of AVM did not improve reproductive outcome. The EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) clinical trial identifier is 2016-002385-31; first registration day 2016-07-11.