To Study the Efficacy of Intrauterine Device and Endometrial Regeneration Therapy versus Endometrial Regeneration Therapy Alone in the Prevention of Adhesions after Hysteroscopic Resection of Uterine Septum

Background: Septate uterus is a very common defect of the female reproductive system. Septate anomalies are associated with diminished fertility and increased risks for adverse pregnancy outcomes. Treatment must aim for optimization of pregnancy outcomes with minimum adverse effects. The aim of this study was to compare the presence or absence of adhesions and assess the efficacy of intrauterine device (IUD) along with endometrial regeneration therapy (ERT) vis-a-vis ERT alone in the prevention of adhesions after hysteroscopic resection of septum. Objectives: (1) To compare the two groups with respect to their efficacy. (2) To analyze the side effects of therapy in each group, e.g., intermittent spotting/bleeding and cyclical pain. (3) To assess endometrial thickness after 3 months, i.e., preovulatory endometrium without therapy. This was a prospective observation study. Materials and Methods: A sample size of 42 was calculated for each study group for comparative analysis and subjects were randomly allocated into one of the two groups using computer-generated randomization tables. Group 1 received IUD and ERT while group 2 received ERT alone. Results: In first group receiving IUD + ERT therapy, 10 patients reported side effects in the form of hypomenorrhea, amenorrhea, severe pelvic pain and prolonged spotting as compared to only 8 patients developing side effects in the second group which received ERT alone therapy.: The rates of postsurgical intrauterine adhesion and other complications were not statistically significant in both groups (P = 0.457). There was no statistically significant difference between the groups with respect to preovulatory endometrial thickness. Conclusion: The findings from this clinical study reconfirm the results of already published efficacy and safety studies of the use of IUD and ERT preventive therapies following hysteroscopic metroplasty.