Prophylactic Antibiotics Prior to Embryo Transfer (PAPET): RCT (PAPET)
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|ClinicalTrials.gov Identifier: NCT03386227|
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Assisted Reproductive Technology Antibiotic Prophylaxis Embryo Transfer||Other: Withholding antibiotic prophylaxis||Not Applicable|
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|
|Actual Study Start Date :||January 21, 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.
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03386227
|Contact: Ashley M Eskew, MDemail@example.com|
|Contact: Emily S Jungheim, MDfirstname.lastname@example.org|
|United States, Missouri|
|Washington University Reproductive Endocrinology||Recruiting|
|Saint Louis, Missouri, United States, 63108|
|Contact: Ashley M Eskew, MD 314-286-2462 email@example.com|