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
Washington University School of Medicine
Information provided by (Responsible Party):
Ashley Eskew, Washington University School of Medicine
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||356 participants|
|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.|
|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|
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 :
- 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 :
- Miscarriage rate [ Time Frame: Prior to 20 weeks gestation in a previously established clinical pregnancy ]Pregnancy loss per clinical pregnancy before 20 weeks
- 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).
- Live birth [ Time Frame: delivery ]Number of live births per embryo transfer
- 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
- 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
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