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

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ClinicalTrials.gov Identifier: NCT03386227
Recruitment Status : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Assisted Reproductive Technology Antibiotic Prophylaxis Embryo Transfer Other: Withholding antibiotic prophylaxis

  Show Detailed Description

Study Design

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
Anticipated Study Start Date : January 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
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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


Eligibility Criteria

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
Criteria

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).
  Study Documents (Full-Text)

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

Publications:

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

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
Microbiome

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