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Abstract
Background Hysteroscopy is the preferred method for the diagnosis and treatment of uterine diseases. With the increasing demand for outpatient hysteroscopy, disposable digital hysteroscopy has emerged, which can meet the requirements of diagnosis and treatment integration, and greatly reduce the labour and storage costs.
Methods A total of 108 outpatients who underwent hysteroscopy using disposable digital hysteroscope were divided into two groups: the non-porous group (group A, n=49) and the married with child group (group B, n=59). The patients’ general information and clinical data were recorded and statistical analysis was performed.
Results No differences were found between the age, weight, body mass index, menopausal status and indication for hysteroscopy of the two groups. The most common indication was embryo transfer failure. The surgical success rate of 108 patients was 100%, the concordance rate between hysteroscopic diagnosis of chronic endometritis and pathological diagnosis was 94.44% (68/72), while the false positive rate stood at 38.89% (14/36). Additionally, incidental findings rate for endometrial polyps was 92.00% (23/25) with a low false positive rate of only 6% (5/83). The mean visual analogue scale score of group A was 2.285±0.180, which was not significantly different from group B (p=0.483, 95% CI(−0.60-0.44)). The pregnancy rate among patients who received assisted reproductive technology and were followed up for 1 year after surgery was 66.67% (40/60), while the abortion rate stood at 5.00% (3/60).
Conclusions The disposable digital hysteroscope is a valuable and effective tool for outpatient hysteroscopy.
- Gynecology
- Uterine Diseases
- Fertility Preservation
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information. -
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WHAT IS ALREADY KNOWN ON THIS TOPIC
With the escalating demand for outpatient hysteroscopy, disposable digital hysteroscope has emerged as a solution to address the drawbacks of reusable hysteroscopy systems, including high cost, challenging maintenance and lengthy disinfection time.
WHAT THIS STUDY ADDS
The concordance rate between hysteroscopic diagnosis of chronic endometritis and pathological diagnosis was 94.44%, while the false positive rate stood at 38.89%. The pregnancy rate among patients who received assisted reproductive technology and were followed up for 1 year after surgery was 66.67%.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Disposable digital hysteroscope exhibits performance that aligns with the requirements of clinical hysteroscopy, particularly in outpatient settings where it can serve as an effective diagnostic and therapeutic tool for infertility and assisted reproduction patients.
Introduction
Hysteroscopy is widely recognised as a predominant minimally invasive surgical technique in the field of gynaecology, for direct visualisation of pathology, but also for histological confirmation through biopsy and potentially enabling the surgeons for needed surgical intervention, serving as the preferred approach for both diagnosing and treatment of uterine cavity disorders. Due to its superior visual diagnostic efficacy compared with transvaginal ultrasound (TVS) and hysterosalpingography, outpatient hysteroscopy is progressively gaining prominence in the realm of assisted reproductive technology (ART).1 Among infertile women with a normal uterine cavity as determined by TVS, the prevalence of abnormal lesions detected through hysteroscopy was found to be 27.6%. Notably, endometrial polyps accounted for 13.1% of these cases, while endometritis was observed in 4%.2 Importantly, addressing and treating these abnormalities can potentially enhance pregnancy outcomes for affected patients.2 3 With the increasing demand for outpatient hysteroscopy, disposable digital hysteroscopes have emerged as a viable solution to address the limitations of reusable hysteroscopy systems, such as their high cost, challenging maintenance requirements and lengthy disinfection time. These disposable instruments offer effortless operation and impeccable visual clarity that is comparable to traditional reusable hysteroscopy instruments. This meets the demands for integrated diagnosis and treatment and helps reduce labour and storage expenses.4 This study analysed the clinical data of 108 patients who underwent disposable digital hysteroscopy aimed to provide practical insights into clinical hysteroscopy, particularly regarding the selection of surgical instruments for outpatient procedures.
Materials and methods
Participants
A total of 108 patients had undergone disposable digital hysteroscopy at People’s Hospital of Guangxi Zhuang Autonomous Region from January 2023 to January 2024; they were divided into two groups: the non-porous group (group A, n=49) and the married with child group (group B, n=59).
Inclusion criteria: (1) age between 18 and 45 years, had reproductive indication; (2) no evident abnormalities by TVS examination; (3) hysteroscopy was necessary following the assessment of the patient’s condition; (4) all hysteroscopies were performed by experienced experts.
Exclusion criteria: (1) excessive uterine bleeding, either during menstruation or outside of the menstrual cycle; (2) congenital reproductive tract abnormalities or aberrations in the cervical canal leading to impaired capacity for normal visualisation; (3) pregnancy, acute pelvic inflammatory disease, severe systemic disease or other contraindications for surgery.
Surgical procedure
All cases underwent hysteroscopy with local anaesthesia using lidocaine for cervical injection; no pain killer or misoprostol was used preoperatively. Disposable digital hysteroscope instruments brand name is ARMI, manufactured by Jiangsu Jiyuan Medical Technology. Hysteroscopy was performed by transvaginal endoscopy; needed procedures such as endometrial biopsy, endometrial polypectomy, intrauterine adhesion separation or cervical adhesion separation were performed based on the patient’s uterine cavity condition. All endometrial tissues removed were histologically confirmed using H&E staining or immunohistochemistry. The diagnostic criteria for chronic endometritis (CE) have not been standardised; diagnosis primarily was made by relying on hysteroscopic view and endometrial biopsy. Typical hysteroscopy features include congestion, oedema and micropolyps. Plasma cells in the endometrial stroma remain the gold standard for diagnosis, with immunohistochemical examination showing positive results for CD38 and CD138. All patients underwent ART following the surgical procedure.
Measures for clinical evaluation
The visual analogue scale (VAS) score was recorded prior to and during the surgical procedure. The amount of blood loss and duration of the operation were documented. Subsequently, experts evaluated the image quality, clarity and adequacy of the surgical field and recorded the operation performance score after operation. A week after surgery, participants were contacted via telephone for follow-up in order to identify any postoperative adverse reactions such as fever, abdominal pain or vaginal bleeding. Three months later, another telephone follow-up was conducted to assess changes in menstrual patterns and detect potential long-term complications like cervical canal adhesion or intrauterine adhesion. Three months after surgery, the participants revisited the hospital for an assessment of their menstrual patterns, alongside a TVS examination to identify any potential long-term complications such as cervical adhesions and intrauterine adhesions.
Statistical analysis
The statistical analysis was performed using SPSS V.21.0 software . Quantitative data were presented as mean±SD. The comparison between the two groups was assessed using t-test. Continuous variables were submitted to Shapiro-Wilk normality test and departed significantly from normal distribution, therefore, the intergroup differences were analysed with the non-parametric Mann-Whitney test. Count data were analysed using χ2 test or Fisher’s exact probability. A bilateral p value <0.05 was considered statistically significant in all analyses conducted.
Results
Patient characteristics
A total of 108 women who fulfilled the inclusion criteria were enrolled in the clinical study analysis (table 1). The average age of these participants was 34.99±4.60, Shapiro-Wilk normality test found that the significance of group A was 0.015, which did not meet the normal distribution. Therefore, Mann-Whitney test was used for data statistics, and it was found that there was no statistically significant difference in age between the two groups (p=0.019). All the patients joined the study due to fertility concerns. Among them, 61 (56.48%) underwent surgery for ‘embryo transfer failure’, while others had reasons such as thin endometrium (14.81%), experiencing recurrent miscarriages (10.19%) or unexplained infertility (18.52%). Following the surgical procedure, they would receive artificial assisted reproduction treatment if indicated. Moreover, none of the women included in this investigation had a history of cervical surgery. There were no significant disparities between these two groups concerning body mass index and indications of operation (p<0.05).
Characteristics of the study participant
The success rate of the operation in 108 patients was 100%, with intraoperative image quality and visual field clarity meeting diagnostic requirements. Among these patients, hysteroscopic diagnosis of CE and other pathological diagnosis was 94.44% (68/72), while the false positive rate (FPR) was 38.89% (14/36). The concordance rate for endometrial polyps was 92.00% (23/25), with an FPR of 6% (5/83). Only one case of submucous leiomyoma and endometrial hyperplasia was identified, resulting in a perfect concordance rate of 100%.
Clinical efficacy
The success rate of the operation in 108 patients was 100%, with intraoperative image quality and visual field clarity meeting diagnostic requirements. Among these patients, the concordance rate for endometrial polyps (figure 1a) was 92.00% (23/25), with an FPR of 6% (5/83). The hysteroscopic diagnosis of CE (figure 1b) and other pathological diagnosis was 94.44% (68/72), while the FPR was 38.89% (14/36). Only one case of submucous leiomyoma and endometrial hyperplasia was identified, resulting in a perfect concordance rate of 100% (table 2).
Hysteroscopic findings. (a) Endometrial polyps. (b) Chronic endometritis.
Hysteroscopic findings
Operative performance
The size of the disposable digital hysteroscope was optional, with a minimum diameter of 3.8 mm, and mechanical cervical dilatation before surgery was not required for all patients. Table 3 presents the outcomes of disposable digital hysteroscope surgery for patients with normal ultrasound results. The average blood loss was 1.407±0.786, the average operation time was 9.33±3.363 and the intraoperative VAS score was 2.342±1.305. There were no statistically significant differences between group A and group B (p=0.700, 95% CI −0.30~0.40; p=0.289, 95% CI −1.86~0.72; p=0.483, 95% CI −0.60~0.44). Abdominal pain was the most common postoperative complication with an incidence rate of 16.67% (18/108). There were no significant differences in incidence between group A and group B (p=0.287).
Surgical data and pregnancy outcomes
The total number of patients who had undergone surgery over a year ago was 67; however, five patients were lost to follow-up and two temporarily abandoned their childbearing plans due to personal reasons. Finally, 60 patients were included in the follow-up analysis: 25 cases in group A and 35 cases in group B. The overall pregnancy rate was found to be 66.67% (40/60), while early pregnancy abortion occurred at a rate of 5.00% (3/60). There were no significant differences observed between group A and group B regarding these outcomes (p<0.05).
Discussion
The intrauterine environment is a crucial determinant of the success rate of embryo transfer in ART. Hysteroscopic surgery has been widely acknowledged as an effective intervention to enhance pregnancy outcomes for patients with intrauterine pathologies, including submucosal uterine fibroids, intrauterine adhesions, endometrial polyps and CE. The procedure of hysteroscopy offers a precise and intuitive evaluation of the structure of the uterine cavity, simultaneously, it facilitates targeted biopsy of lesions.5 6 Hysteroscopy is widely recognised as the gold standard for diagnosing intrauterine diseases, in contrast to alternative diagnostic techniques like TVS.6 The incidence of intrauterine abnormalities detected during hysteroscopy in cases with previously normal TVS findings has been reported to range from 11% to 32%.7 8 Monteiro et al conducted a retrospective cross-sectional study on 1141 consecutive women who underwent outpatient hysteroscopy before ART; the study reported that the sensitivity of TVS varied from 8% for uterine synechiae to 41% for submucous leiomyoma, resulting in low likelihood ratios for negative TVS results.9 In this study, the TVS negative patients primarily consisted of individuals with a history of repeated embryo transfer failure, recurrent miscarriage and thin endometrium prior to transplantation. The incidence of intrauterine adhesion observed during hysteroscopy was 34.26%, while endometrial biopsy during operation revealed an occurrence rate of 66.67% for endometritis, while the FPR was 38.89%. The reason for this high FPR may be that the current criteria for the diagnosis of CE under hysteroscopy are not absolutely specific, for example, some endometrial polyps or intrauterine adhesions may show endometrial flushing or small polypoid changes, in addition, there may be pathological specimen sampling bias or too few specimens to support the immunohistochemical diagnosis. Additionally, the prevalence of endometrial polyps was found to be 23.15%, the findings agreed with other hysteroscopy studies in over 90% of cases.
However, a 2023 meta-analysis demonstrated that routine hysteroscopy prior to ART treatment improved the clinical pregnancy rate but did not significantly enhance the live birth rate. The Chinese Society of Reproductive Medicine reports that the clinical pregnancy rate for embryo transfer in Chinese women of reproductive age undergoing ART is between 51.95% and 52.23%, while the live birth rate ranges from 41.46% to 42.39%.10 In our study, patients who underwent disposable digital hysteroscopy within 1 year after surgery had a pregnancy rate of 66.67%. Based on these data, we believe that success rates in ART are influenced by multiple factors. Although there is no conclusive clinical evidence supporting routine hysteroscopy before ART, it enables the surgeon to thoroughly evaluate the uterine cavity environment before conception for any undiagnosed hidden pathology, such as CE. CE is a localised mucosal infectious and inflammatory disease that accounts for up to 9–67% of recurrent pregnancy loss and 30.3% of recurrent implantation failure among women due to delayed endometrial maturation caused by endometritis leading to asynchrony with implantation. Although false negatives exist, coincidence rates with pathological diagnosis reach as high as 94.44%. In light of vague diagnostic criteria for CE, combining it with hysteroscopy can significantly increase diagnostic accuracy.11 Intrauterine adhesions also play an important role in infertility and recurrent miscarriage which can be easily detected through hysteroscopy. Despite three-dimensional colour Doppler ultrasound’s sensitivity reaching up to 91.9%, hysteroscopy remains the gold standard for diagnosis since it allows evaluation of adhesion extent/location and simultaneous treatment administration.5 12 In this study, the detection rate of intrauterine adhesions was found to be 34.26% using disposable digital hysteroscopy even when TVS results were normal. Thus, hysteroscopy provides valuable assurance information. In conclusion, hysteroscopy remains a reliable method to ensure optimal evaluation of the uterine cavity environment prior to pregnancy and enhance the success rate of patients undergoing ART, particularly in cases of recurrent implantation failure and repeated miscarriage. However, given the limited sample size and short follow-up duration in this study, it is imperative to further expand the sample size and extend the follow-up period for a comprehensive understanding of patient pregnancy outcomes.
The disposable digital hysteroscopy operating systems used in our clinical study consist of an electronic hysteroscopy imaging catheter, which primarily comprises a head end (including Light emitting diode lighting, optical lens and complementary metal-oxide-semiconductor imaging module), insertion part (including instrument channel and shared injection channel), handle, cable and connector. The head end possesses image and video acquisition capabilities. The insertion site allows for smooth instrument operation during hysteroscopy procedures, catering to the integration of diagnosis and treatment as well as medical teaching and research requirements. Zeng et al conducted a multicentre randomised controlled study comparing disposable digital hysteroscopy with reusable hysteroscopy in outpatient settings. The results demonstrated that the experimental group achieved a clinical diagnosis coincidence rate of 98.78% (80/82), while the control group achieved a clinical diagnosis coincidence rate of 100% (82/82), meeting the eligibility criteria.4
Vaginal endoscopy, a novel technique in the realm of minimally invasive gynaecological diagnosis and treatment, has emerged as an alternative to traditional hysteroscopy. This innovative approach demonstrates a notable reduction in patient discomfort and pain during examinations when compared with conventional methods. Peng et al have shown that vaginal endoscopy significantly decreases patient VAS scores and operation time and enhances both operator and patient satisfaction. However, no statistically significant difference was observed in the incidence of complications.13 14 Both the American Association of Obstetricians and Gynecologists and the American Association of Gynecological Laparoscopy recommend considering the use of vaginal endoscopic techniques for outpatient hysteroscopy.
The success rate of disposable hysteroscopy by transvaginal endoscopy was 100% in all 108 cases included in our study. The surgical field and performance both demonstrated exceptional adherence to clinical diagnostic and treatment requirements. The average intraoperative VAS score was only 2.342±1.305, while the duration of surgery was brief (9.33±3.363 min), and the amount of intraoperative blood loss was minimal (1.407±0.786 mL). It is worth noting that there were no significant differences observed between nulliparous and pregnant patients, and postoperative complications were reduced without notable distinctions found between group A and group B. These findings suggest the advantages of disposable digital hysteroscopy using transvaginal endoscopic technique in an outpatient setting, particularly in alleviating the distress experienced by nulliparous women. In comparison to traditional reusable hysteroscopes, its advantages include the following: (1) disposable products eliminate cross-infection risks for patients with infectious diseases; (2) no cleaning or disinfection is required while avoiding potential damage to the lens body maintenance; there are no quantity or space limitations resulting in time-saving benefits along with reduced labour costs; (3) has a minimum insertion diameter of 3.8 mm compatible with uterine instruments significantly reducing pain experienced by nulliparous women; it also offers substantial advantages in vaginal endoscopic hysteroscopy for women without sexual activity or menopausal women. Therefore, we believe that disposable electric hysteroscopy is a safe and effective approach for diagnosing and treating uterine cavity lesions among outpatients due to its low-cost nature combined with wide applicability meeting various clinical demands.
Conclusion
In conclusion, this prospective randomised trial was conducted to assess the safety and efficacy of disposable digital hysteroscope in terms of clinical outcomes and operator experience. The findings demonstrated favourable field of view and a satisfactory operator experience with disposable digital hysteroscopy. Furthermore, it provided us with the capability of simultaneous examination and treatment, while the utilisation of advanced devices effectively mitigated pain in nulliparous patients. Moreover, postoperative adverse reactions were minimal. Consequently, the disposable digital hysteroscope demonstrates performance that aligns with the requirements of clinical hysteroscopy, particularly in outpatient settings where it can serve as an efficient diagnostic and therapeutic tool for infertility and assisted reproduction patients.
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information. -
Ethics statements
Patient consent for publication
Ethics approval
This study involved human participants and was approved by the ethics committee of the People’s Hospital of Guangxi Zhuang Autonomous Region (ID: KY-IIT-2024-54). Informed consent documents were signed by all participants before surgery. Participants gave informed consent to participate in the study before taking part.
Footnotes
Contributors DJ is the guarantor and responsible for conceptualisation, methodology, formal analysis, investigation and writing–original draft. LD was responsible for formal analysis, investigation and project administration. RP, AS, JS and LF were responsible for writing–review and editing and supervision. DJ accepted full responsibility for the finished work and/or the conduct of the study, had access to the data and controlled the decision to publish.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests RP and JS have served as the editorial members of GOCM. All other authors declare no competing interest.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.