Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions.

OBJECTIVE: To evaluate the efficacy of freeze-dried amnion graft for prevention of intrauterine adhesion (IUA) reformation after hysteroscopic adhesiolysis.

METHODS: A prospective randomized controlled trial was conducted among 88 women with severe IUAs who underwent hysteroscopic adhesiolysis at Beijing Obstetrics and Gynecology Hospital between July 15, 2015, and July 1, 2016. All participants had a balloon inserted into the uterine cavity for 1 week. Sterilized freeze-dried amnion graft covered the balloon portion of the Foley catheter among patients allocated to the amnion group (n=44), whereas patients in the control group (n=44) did not receive the graft. Follow-up hysteroscopy was performed 3 months after surgery. Preoperative and postoperative IUA scores, menstruation scores, and pregnancy rates were assessed.

RESULTS: Both groups exhibited reductions in IUA scores and improvements in menstruation scores following treatment (P<0.001 for each measure). Compared with the control group, the amnion group had a lower IUA score (P=0.032) and a higher menstruation score (P<0.001) at follow-up. By contrast, the rates of IUA reformation and pregnancy were not significantly different between the two groups.

CONCLUSION: Use of freeze-dried amnion graft was effective in reducing IUA reformation and improving menstruation (according to pictorial blood-loss assessment chart) following hysteroscopic adhesiolysis of severe IUAs. ClinicalTrials.gov: (NCT02496052).