OBJECTIVE: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance.
DESIGN: Multicenter prospective randomized trial.
SETTING: One university and seven university-affiliated teaching hospitals.
PATIENT(S): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed.
INTERVENTION(S): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome.
MAIN OUTCOME MEASURE(S): Reproductive outcomes during the 12 months after the D&C procedure.
RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71% (46/64) and 59.7% (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively.
CONCLUSION(S): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes.
CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.
|Number of pages||8|
|Journal||Fertility and Sterility|
|Publication status||Published - Dec 2018|