A Randomized Controlled Clinical Study:evaluating The Effect Of Collagen Scaffold On Intrauterine Adhesion Recurrence After Adhesiolysis For The Patients With Mild To Moderate Intrauterine Adhesions

Objective:To assess the clinical safety and effectiveness of collagen scaffold for the prevention of adhesion reformation after hysteroscopic adhesiolysis in patients with mild to moderate intrauterine adhesions(IUAs).Subjects and methods:This is a prospective randomized controlled study.Subjects are patients with mild to moderate IUA who wants to be pregnant in Nanjing Drum Tower Hospital from March 2018 to February 2019.They were randomly divided into two groups namely study group-collagen scaffold group and control group-intrauterine device group,IUD group.After hysteroscopic adhesiolysis,collagen scaffold was placed into the uterine cavity in study group or inertia ring was placed in control group.All cases were given hormone therapy for 2 months(2mg oral estradiol daily for 20 days,followed by 2mg estradiol/10mg dydrogesterone daily for 7 days began in the third day of menstruation).A transvaginal ultrasound scan and a second-look hysteroscopy were carried out 2 months after the adhesiolysis in the late proliferative phase and meanwhile,IUD was removed in control group.Document incidence of adverse events,adhesion reformation,endometrial thickness and menstrual blood volume postoperatively,and follow up the reproductive outcomes.Results:Ninety four cases were recruited,6 cases lost to follow-up and 2 cases dropped out.Eighty six cases were finally included to calculate:42 cases in study group with 9 cases mild IUA and 33 cases moderate IUA and 44 cases in control group with 12 cases of mild IUA and 32 cases of moderate IUA.There is no statistical difference in age,gravidity and parity history,BMI,etiology,amenorrhea history,adhesiolysis history and menstrual blood volume between two groups.No uterine perforation and infection took place during studying period.In study group,9.5%(4/42)patients presented adhesion reformation after surgery,while,in control group was 25.0%(11/44).However,the difference wasn't statistically significant(p>0.05).The reformation rate of mild IUA was 11.1%(1/9)in study group and 8.3%(1/12)in control group,and there has no statistical significance(p>0.05).The reformation rate of moderate IUA in study group was 9.1%(3/33),significantly lower than that 31.3%(10/32)of control group(p<0.05).Postoperative endometrial thickness and menstrual blood volume were higher than that before adhesiolysis(p<0.05).Following up at least half a year(time of adhesiolysis was range from March 17,2018 to November 8,2019).Twenty six people were pregnant in 48 people who were scheduled a pregnancy plan.The total pregnancy rate was 54.2%(26/48)including 57.7%(15/26)continuous pregnancy,76.9%(20/26)clinical pregnancy,3.8%(1/26)miscarriage,and 19.2%(5/26)biochemical pregnancy.There is no statistical difference in rate of total pregnancy,continuous pregnancy,clinical pregnancy,miscarriage and biochemical pregnancy between two groups(p>0.05).Conclusion:It is safe that using collagen scaffold to prevent intrauterine adhesion.Comparing to IUD,collagen scaffold seems to have a better effect in preventing adhesion reformation in moderate IUA.However,the pregnancy outcome remains a longer follow-up.