Medicine and Health

Comparing the efficacy and pregnancy outcome of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis in infertile women: a prospective, randomized, controlled trial study

Q. Zhang, H. Ding, et al.

This groundbreaking trial led by Qing Zhang and colleagues explores the effectiveness of intrauterine balloons versus IUDs in preventing adhesion reformation after hysteroscopic adhesiolysis. Discover how these interventions could enhance treatment outcomes for infertile women facing moderate to severe intrauterine adhesions.

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Playback language: English

Index

Introduction

Intrauterine adhesions (IUAs), also known as Asherman's syndrome, are a significant cause of infertility, often resulting from uterine trauma, infection, or surgery. The most common cause is dilation and curettage (D&C), particularly after miscarriage. IUAs lead to reduced menstrual flow, amenorrhea, pain, and infertility. Treatment involves hysteroscopic adhesiolysis to restore uterine cavity volume and shape. However, adhesion reformation is a major challenge, with recurrence rates as high as 62.5% in severe cases. Various methods have been proposed to prevent readhesion, including IUD placement and Foley catheter balloon insertion. IUDs are frequently used to maintain uterine cavity patency and promote endometrial regeneration, while balloons help separate wound surfaces and drain exudates. This study aimed to compare the efficacy and pregnancy outcomes of these two methods in preventing IUA reformation after hysteroscopic adhesiolysis in infertile women with moderate to severe IUAs.

Literature Review

The literature extensively discusses the challenges of IUA treatment and prevention of readhesion. Studies highlight the use of IUDs post-adhesiolysis, with varying durations of placement. The optimal duration for IUD placement remains unclear. Other studies explore the use of intrauterine balloons, emphasizing their role in separating wound surfaces and reducing infection risk by draining exudates. A randomized controlled trial (RCT) has shown similar efficacy between IUD and balloon placement in preventing adhesion recurrence. However, a universal standard for IUA prevention remains absent. This study builds on existing research to provide a more comprehensive comparison of IUD and balloon therapy in preventing IUA reformation.

Methodology

This prospective, randomized, controlled trial enrolled 130 infertile women with moderate to severe IUAs (AFS score 5-12). Patients were randomly assigned to one of three groups: (A) IUD placement for one month, (B) IUD placement for two months, and (C) Foley catheter balloon placement for five days. All patients underwent hysteroscopic adhesiolysis followed by their assigned intervention. Postoperatively, all patients received antibiotics and hormone therapy. A second-look hysteroscopy was performed one month after surgery (balloon group) or 1-2 months post surgery (IUD groups) to assess adhesion reformation using the AFS score. Endometrial thickness was also measured. Pregnancy outcomes following embryo transfer were recorded. Data were analyzed using one-way ANOVA and Chi-square test. A p-value <0.05 was considered statistically significant.

Key Findings

A total of 129 patients completed the study. All three groups showed a significant reduction in AFS scores after the initial procedure (p<0.05). The balloon group exhibited a greater reduction in AFS score compared to the IUD groups. However, no statistically significant difference was found between the one-month and two-month IUD groups in terms of AFS score reduction, endometrial thickness improvement or pregnancy rates. Endometrial thickness significantly increased in all three groups after surgery, but the degree of increase was not statistically different among groups. Pregnancy rates were similar across the three groups (approximately 23-25% in each). There were also no significant differences among groups in rates of miscarriage, ectopic pregnancy or premature delivery.

Discussion

The findings indicate that both intrauterine balloon and IUD placement are effective strategies for preventing IUA reformation after hysteroscopic adhesiolysis. The superior reduction in AFS score observed in the balloon group suggests that it may be more effective in restoring uterine morphology. However, the lack of significant differences in endometrial thickness and pregnancy rates among the three groups highlights the importance of other factors influencing pregnancy outcomes. This study supports the use of shorter IUD placement durations (one month) since there is no added benefit to extending the placement to two months. Further research should focus on optimizing uterine repair and potentially combining therapeutic approaches to enhance pregnancy outcomes.

Conclusion

This study demonstrates the efficacy of both intrauterine balloon and IUD placement in preventing IUA recurrence after hysteroscopic adhesiolysis. While the balloon showed superior efficacy in restoring uterine morphology, the pregnancy outcomes were similar across all three groups, suggesting that other factors influence reproductive outcomes. Shorter IUD placement durations may be sufficient. Future research should explore combined therapies and identify factors influencing pregnancy success in IUA patients.

Limitations

The study's limitations include its single-center design and relatively small sample size, which may limit the generalizability of the findings. The study also lacked detailed reporting on patient compliance with hormone therapy and adverse events, which would further enhance interpretation of treatment benefits and risks. Additionally, a lack of long-term follow-up on pregnancy outcomes and patient feedback limits the scope of the study's conclusions. The absence of a standard treatment group prevents a definitive assessment of the relative efficacy of balloon and IUD compared to standard care.

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