Prophylactic Antibiotics Prior to Embryo Transfer (PAPET): RCT
Stopped early · Not applicable
Conditions studied: Assisted Reproductive Technology, Antibiotic Prophylaxis, Embryo Transfer
In brief
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
Key facts
- Study ID
- NCT03386227
- Run by
- Washington University School of Medicine
- People needed
- 96
- Starts
- 2018-01-21
- Expected to finish
- 2019-07-31
- Last updated by the study team
- 2020-08-18
Who can join
Age: 18 and older, up to 43. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- The female partner must be aged 18-43 years and going through a fresh IVF cycle
You may not qualify if…
- 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.
Where it is running
- Washington University Reproductive Endocrinology — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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