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Prophylactic Antibiotics Prior to Embryo Transfer (PAPET): RCT

NCT03386227 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-08-18

No results posted yet for this study

Summary

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

Conditions

  • Assisted Reproductive Technology
  • Antibiotic Prophylaxis
  • Embryo Transfer

Interventions

OTHER

Withholding antibiotic prophylaxis

Our intervention will be a deviation from our current standard of care which is universal antibiotic prophylaxis, even in low risk populations. Our intervention will be withholding antibiotic prophylaxis in low risk populations.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-21
Primary Completion
2019-06-30
Completion
2019-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386227 on ClinicalTrials.gov