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Prophylactic Antibiotics Prior to Embryo Transfer (PAPET): RCT (PAPET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03386227
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : August 9, 2018
Information provided by (Responsible Party):
Ashley Eskew, Washington University School of Medicine

Brief 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 a pilot RCT will be conducted among the first 50 patients undergoing their first cycle enrolled to evaluate the microbiome across the IVF cycle, in addition to the human virome.

Condition or disease Intervention/treatment Phase
Assisted Reproductive Technology Antibiotic Prophylaxis Embryo Transfer Other: Withholding antibiotic prophylaxis Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will have patients randomized in a 1:1 fashion to antibiotic prophylaxis or withholding antibiotic prophylaxis.
Masking: Single (Outcomes Assessor)
Masking Description: The embryologists who assess embryo outcomes (as noted in the secondary outcomes) will be blinded to randomization.
Primary Purpose: Other
Official Title: Prophylactic Antibiotics Prior to Embryo Transfer: a Randomized Controlled Trial
Actual Study Start Date : January 21, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
No Intervention: Prophylactic antibiotics
Current standard of care in our practice for a fresh in vitro fertilization cycle is to administer one dose of 1 gram oral azithromycin on day one of the IVF cycle start to both the male and female partner. In cases of same-sex couples, only the female undergoing the embryo transfer receives prophylaxis. This will serve as our control arm entitled: prophylactic antibiotics.
Experimental: No antibiotic prophylaxis.
Couples randomized to the no-antibiotic treatment group will not be prescribed oral antibiotic prophylaxis.
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.

Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: Our primary outcome measure will be obtained at 5-8 weeks gestational age following embryo transfer ]
    Defined as a gestational sac, with fetal pole and cardiac activity, on ultrasound

Secondary Outcome Measures :
  1. Miscarriage rate [ Time Frame: Prior to 20 weeks gestation in a previously established clinical pregnancy ]
    Pregnancy loss per clinical pregnancy before 20 weeks

  2. Embryo development [ Time Frame: Intraoperative (This outcome measure will be assessed from the time of egg retrieval to embryo transfer or embryo cryopreservation) ]
    As evaluated by fertilization rate (number of two-pronuclei embryos per mature oocyte), blastocyst conversion rate (number of day 5 embryos from two-pronuclei embryos), and blastocyst utilization rate (number of day 5 embryos transferred or frozen per two-pronuclei embryos).

  3. Live birth [ Time Frame: delivery ]
    Number of live births per embryo transfer

  4. Reproductive Tract Microbiome [ Time Frame: Approximately 30 days from start of IVF cycle ]
    Swabs will be obtained across the IVF cycle to evaluate changes in the reproductive tract microbiome

  5. Reproductive Tract Virome [ Time Frame: Intraoperative (At the time of embryo transfer) ]
    Swabs will be obtained at the time of embryo transfer to evaluate the virome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The female partner must be aged 18-43 years and going through a fresh IVF cycle

Exclusion Criteria:

  • Couples will be excluded from enrollment if they have any contraindication to antibiotic treatment, are not intending to undergo embryo transfer (fertility preservation patients and oocyte donors), require use of extended antibiotic coverage at time of egg retrieval, are already on antibiotics for any reason (e.g., upper respiratory infection), have a recent history of pelvic infection, or are planning on limited insemination (inseminating a limited number of the eggs retrieved) or are using donor sperm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03386227

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Contact: Ashley M Eskew, MD 214-286-2462
Contact: Emily S Jungheim, MD

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United States, Missouri
Washington University Reproductive Endocrinology Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Ashley M Eskew, MD    314-286-2462   
Sponsors and Collaborators
Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Ashley Eskew, Washington University School of Medicine:


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Responsible Party: Ashley Eskew, Principal Investigator, Washington University School of Medicine Identifier: NCT03386227     History of Changes
Other Study ID Numbers: WashingtonU_REI
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ashley Eskew, Washington University School of Medicine:
Assisted Reproductive Technology
Antibiotic Prophylaxis

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents