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NCT03386227: PAPET

Prophylactic Antibiotics Prior to Embryo Transfer (PAPET): RCT

Terminated NA Last updated 18 August 2020
What this trial tests

NA trial testing Withholding antibiotic prophylaxis in Assisted Reproductive Technology in 96 participants. Terminated before completion.

Timeline
21 January 2018
Primary endpoint
30 June 2019
31 July 2019

Quick facts

Lead sponsorWashington University School of Medicine
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment96
Start date21 January 2018
Primary completion30 June 2019
Estimated completion31 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 43, any sex, with Assisted Reproductive Technology or Antibiotic Prophylaxis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to determine the impact on clinical pregnancy rate of withholding routine prophylactic antibiotic therapy during IVF. The hypothesis is that withholding antibiotic prophylaxis will be non-inferior to routine administration. To test this hypothesis, the investigators will conduct a randomized controlled non inferiority trial. Additionally an exploratory study will be conducted among the first 30 patients undergoing their first cycle enrolled to evaluate the microbiome across the IVF cycle, in addition to the human virome

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Association of vaginal bacterial communities and reproductive outcomes with prophylactic antibiotic exposure in a subfertile population undergoing in vitro fertilization: a prospective exploratory study.
    Eskew AM, Stout MJ, Bedrick BS, Riley JK, et al · · 2021 · cited 11× · PMID 34632426 · DOI 10.1016/j.xfss.2021.01.002

Verify or expand the search:

Other recruiting trials for Assisted Reproductive Technology

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03386227.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing