Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomised, double blind, multi-centre, stratified, superiority trial.

OBJECTIVE: To study the effectiveness of a new intrauterine degradable polymer film (Womed Leaf®) in the management of moderate to severe IUA. DESIGN: PREG2 study was a multi-centre, double-blind, randomised, controlled, stratified, two-arm superiority clinical trial conducted in 16 centres in 7 countries. SUBJECTS: Patients ≥18 years scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (according to American fertility society (AFS) IUA score) were considered eligible for the study. INTERVENTION: Following adhesiolysis, patients were randomised at a 1:1 ratio to either have a Womed Leaf film inserted (intervention group) or not (control group). MAIN OUTCOME MEASURES: The primary effectiveness endpoint of the study was the change in AFS IUA score on second-look hysteroscopy (SLH), assessed by an independent evaluator, compared to baseline. Information on rate of no IUA and responder rate were collected as secondary effectiveness outcomes, and reported adverse events and patient reported outcomes as safety and tolerability measures. RESULTS: Between October 26, 2021, and September 28, 2023, a total of 160 women were randomised (Womed Leaf: n=75 and controls: n=85). The reduction in IUA AFS score on SLH was significantly higher in the intervention compared to the control group (mean 5.2 ± 2.8 vs. 4.2 ± 3.2; p=0.0153). Similarly, the absence of adhesions on SLH was significantly higher in the intervention group (41% vs 24% OR 2.44 [CI 1.161 - 5.116]; p=0.0189). None of the reported adverse events were serious or considered related to the device. CONCLUSION: Womed Leaf is effective and safe in the management of symptomatic severe or moderate intrauterine adhesions.

A Controversial Old Topic Revisited: Should Diagnostic Hysteroscopy Be Routinely Performed Prior to the First IVF Cycle? A Systematic Review and Updated Meta-analysis.

OBJECTIVE: This systematic review and meta-analysis aimed to analyze the impact of performing diagnostic hysteroscopy before the first in vitro fertilization (IVF) cycle on the clinical pregnancy rate and live birth. DATA SOURCES: PubMed-MEDLINE, Embase, Web of Science, The Cochrane Library, Gynecology and Fertility Specialized Register of Controlled Trials, and Google Scholar were consulted from inception to June 2022 using combinations of the relevant Medical Subject Headings terms and keywords. The search included major clinical trial registries such as ClinicalTrials.gov and the European EudraCT registry without language restrictions. In addition, manual cross-reference searches were also performed. METHODS OF STUDY SELECTION: All randomized and controlled clinical trials, prospective and retrospective cohort studies, and case-control studies comparing the probability of pregnancy and live birth among patients who underwent diagnostic hysteroscopy with possible treatment of any abnormal findings before the IVF cycle and patients who underwent the IVF cycle directly have been considered for inclusion. Studies with insufficient information on the results of interest or without the necessary information to perform the pooled analysis, those without a control group or with end points considered different than those of interest, were excluded. The review protocol was registered in PROSPERO (CRD42022354764). TABULATION, INTEGRATION, AND RESULTS: A total of 12 studies were included in the quantitative synthesis, reporting the reproductive outcomes of 5056 patients undergoing ART treatment for the first time. Selected studies included 6 randomized controlled trials, 1 prospective cohort study, 3 retrospective cohort studies, and 2 case-control studies. The likelihood of clinical pregnancy of patients undergoing hysteroscopy before IVF was significantly higher than those without hysteroscopy (odds ratio [OR], 1.49; 95% confidence CI 1.16-1.91; I2 = 69%). (odds ratio [OR], 1.51; 95% confidence interval [CI], 1.22-1.88; I2 59%). Eight studies included live birth rate; no statistically significant differences were found between the 2 groups for this outcome (OR,1.24; 95% CI, 0.94-1.64; I2 = 62%). Subsequently, a sensitivity analysis was performed, including only randomized clinical trials. Clinical pregnancy OR of patients undergoing hysteroscopy before starting the IVF cycle remained significantly higher than the control group (OR,1.62, 95% CI, 1.15-2.29; I2 = 62%). Risk of bias assessment was performed using the Grading of Recommendations Assessment, Development, and Evaluation. CONCLUSION: The available scientific evidence suggests that performing routine hysteroscopy before the first IVF attempt improves the clinical pregnancy rate; however, the live birth rate is unaffected.

Hysteroscopic metroplasty for the treatment of the dysmorphic uterus: A SWOT analysis.

Introduction: Dysmorphic uterus or T-shaped uterus is an increasingly frequent diagnosis among the infertile population that has been associated to worse reproductive results. Hysteroscopic metroplasty is a safe and simple procedure that can improve the reproductive outcomes in this group of patients, although the benefits of this procedure remains controversial due to the lack of adequate scientific evidence. Objective: To analyze the hysteroscopic metroplasty using the SWOT (Strengths, Weaknesses, Opportunities and Threats) methodology. Data sources: An electronic search from inception each database up to December 2021 including the following databases was conducted: PubMed-MEDLINE, EMBASE, Web of Science, The Cochrane Library, and Google Scholar. Methods of study selection: Studies reporting outcomes of patients undergoing hysteroscopic metroplasty were included. Tabulation: Not applicable. Integration and Results: Clinical evidence from the included studies suggests an improvement in reproductive results after performing hysteroscopic metroplasty especially in women with recurrent pregnancy loss and previous infertility, but all of them have relevant methodological limitations. For this reason, benefits, risks and alternatives of this intervention should be considered with caution. Conclusions: Evidence from published data shows a probable association between dysmorphic uterus and poor reproductive outcomes. Hysteroscopic metroplasty in patients with dysmorphic uterus could improve pregnancy outcomes, but there is need of properly designed prospective controlled studies to determine the benefits of this technique.

Effect of Hysteroscopic Metroplasty on Reproductive Outcomes in Women with Septate Uterus: Systematic Review and Meta-Analysis.

OBJECTIVE: The aim of this systematic review with meta-analysis is to evaluate the impact of hysteroscopic metroplasty on adverse reproductive outcomes such as miscarriage, preterm birth, and fetal malpresentation in patients with history of infertility or previous poor obstetrical outcomes. DATA SOURCES: A systematic electronic search from inception each database up to April 2021 including the following databases was conducted: PubMed-MEDLINE, EMBASE, Web of Science, The Cochrane Library, the CGF Specialized Register of Controlled Trials, Google Scholar, and trial registries. A combination of the following keywords was used: uterine septum, septate uterus, congenital uterine malformation, class 2 uterus, class V uterus, metroplasty, hysteroscopic, pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, live birth, preterm birth, cesarean section, 'cesarean delivery, and fetal malpresentation. METHODS OF STUDY SELECTION: Studies comparing reproductive outcomes between women undergoing hysteroscopic resection of the uterine septum and those with expectant management were included. Eligible population consisted of infertile women, women with poor obstetrical history, or women without previous pregnancy failures and a diagnosis of septate uterus. TABULATION, INTEGRATION, AND RESULTS: The systematic electronic search retrieved 1076 studies; after elimination of duplicates, 688 titles and abstracts were screened, and 55 were assessed for eligibility. Eleven studies were included in the quantitative synthesis: one randomized controlled trial and 10 observational studies involving reproductive outcomes from 1589 patients with either complete or partial uterine septum. The pooled OR for miscarriage was 0.45, (95% CI, 0.22-0.90). When the analysis was performed considering subgroups according to the type of septum, pooled OR in complete septum subgroup was 0.16 (95% CI, 0.03-0.78), OR = 0.36 (95% CI, 0.19-0.71) in the partial septum subgroup and 0.58 (95% CI, 0.20-1.67) in those studies not differentiating between complete or partial septum. No significant differences were found between the 2 groups in OR of clinical pregnancy, term live birth, or risk of cesarean delivery. There was a significant decrease in the frequency of preterm birth in patients who underwent partial septum resection (OR = 0.30, 95% CI, 0.11-0.79). This difference was detected neither in patients with complete septum nor in studies not differentiating between partial or complete septum. The risk of fetal malpresentation was also significantly reduced (OR = 0.32, 95% CI, 0.16-0.65). CONCLUSION: The results of the present meta-analysis support that hysteroscopic metroplasty is effective in reducing the risk of miscarriage in patients with complete or partial uterine septum, although these data should be confirmed with a well-designed randomized controlled trial.

Office hysteroscopic myomectomy without myoma extraction: A multicenter prospective study.

OBJECTIVE: To evaluate the feasibility and safety of leaving the submucous myoma (SM) in the uterine cavity after office hysteroscopic enucleation. STUDY DESIGN: Prospective multicenter study including patients who had a single SM diagnosed by transvaginal ultrasounds with surgical indication. Office hysteroscopic enucleation of the SM was performed using a 5 mm continuous flow office hysteroscope with a 2.9 mm rod lens optical system and a 5 Fr operative channel. After the SM was released preserving the pseudo capsule using cold instruments, it was left into the uterine cavity. The primary endpoint was the proportion of patients without evidence of the myoma at the transvaginal ultrasound performed after 90 days from surgery. RESULTS: Between January 1st, 2018, and March 31st, 2020, a total of 204 patients were enrolled. Most patients were nulliparous and reported abnormal uterine bleeding as the leading symptom. 76.5 % of enucleated myomas had a diameter ranging between 1.5 and 2.5 cm, and 81.4 % of SMs were of G0 or G1. Hysteroscopic procedures had a mean duration of 23.2 ± 10.5 min. The operative time was associated with the SM grade and size. All hysteroscopic procedures were completed. A vasovagal reaction was observed in 3 women (1.5 %), and minimal post-operative bleeding was reported after 7 procedures (3.4 %). None reported pelvic pain or vaginal discharges/bleeding during follow-up. The average patient satisfaction from surgery was 4.59 (5-points Likert scale). The level of patient satisfaction was not associated with the grade and the size of the myoma. In 192 (94.12 %; 98 %CI: 89.03-96.93 %) out of 204 patients, the SM was absent at the transvaginal ultrasound performed at the follow-up end. A higher prevalence of G2 SMs and lower prevalence of G1 SMs were observed among patients with evidence of the myoma after 90 days from the surgery. CONCLUSION: Office hysteroscopic myomectomy with SM enucleation without mass extraction appears safe, well-tolerated, and effective in at least 89 % of patients. G2 SMs may be the factor associated with the procedure's failure.