To study the safety of DPF (degradable polymeric film) and its efficacy on reducing the risk of intrauterine adhesions (IUA) formation in a rat model.
A series of Case control studies relying on random allocation where feasible.
University and good practice animal laboratories.
Animal models comprised female and male OFA (Oncins France Strain A) and female wistar rats.
OFA rats were used for in vivo evaluation of the impact of DPF on endometrial thickness and in vivo evaluation of the effect on fertility. For in vivo evaluation of the biological response, 40 wistar rats were randomly allocated to intervention and control groups with matched sampling time after surgery. Finally, for the in vivo evaluation of DPF efficacy on IUA prevention, a total of 24 wistar rats were divided into 3 groups that were treated with DPF, hyaluronic acid (HA) gel and a sham group.
DPF did not have a significant impact on endometrial thickness and no significant differences in the number of conceived or prematurely terminated pregnancies confirmed its non-inferiority to no treatment. DPF did not induce irritation at 5 and 28 days. Finally, DPF significantly reduced the likelihood of complete IUA formation compared to HA gel and sham implanted animals, where only 27% of the animals had their uterine cavity obliterated compared to 80% and 100% respectively.
DPF is a safe degradable polymeric film that is effective in preventing IUA formation after intrauterine curettage in rats.
Copyright © 2020. Published by Elsevier Inc.