Menopausal Patients Research Articles

Perfluorohexyloctane eye drops for dry eye disease associated with meibomian gland dysfunction: A subgroup analysis by menopausal status from a phase 3 trial

Aims/Purpose: In a randomized, double‐masked, phase 3 trial (NCT05515471), perfluorohexyloctane eye drops effectively improved signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). This post‐hoc analysis of the phase 3 trial provides efficacy and safety results by menopausal status subgroup.Methods: As previously detailed, patients with DED associated with MGD were randomly assigned 1: 1 to receive perfluorohexyloctane eye drops or 0.6% sodium chloride [NaCl]). Primary endpoints were changes from baseline in total corneal fluorescein staining (tCFS) and eye dryness scores at day 57. Menopause was defined as at least 12 consecutive months without menstruation. A random effects model adjusted for center and baseline values analyzed the efficacy data.Results: In total, 94 patients were menopausal (48 on perfluorohexyloctane, 46 on NaCl) and 151 patients were premenopausal (70 on perfluorohexyloctane, 81 on NaCl). At day 57, premenopausal patients treated with perfluorohexyloctane showed greater decreases from baseline in tCFS score and eye dryness score than the NaCl group, with differences between treatment groups of ‐1.35 (95% CI: ‐2.22, ‐0.48) and ‐14.51 (95% CI: ‐20.85, ‐8.17), respectively. In menopausal patients, decreases from baseline in tCFS score and eye dryness score at day 57 were noted in the perfluorohexyloctane group, with no evidence of between‐group differences (tCFS score difference: ‐0.98, 95% CI: ‐1.98, 0.03; eye dryness score difference: ‐7.09, 95% CI: ‐15.12, 0.94). Perfluorohexyloctane led to significantly greater improvements in burning/stinging sensation, awareness of DED symptoms, frequency of dryness, and ocular surface disease index score in both subgroups. Perfluorohexyloctane were well‐tolerated with similar safety profiles across subgroups.Conclusions: Perfluorohexyloctane eye drops showed efficacy and well tolerability for DED associated with MGD in both menopausal and premenopausal patients.

Finding ways to correct nonspecific vaginitis in menopausal women with obesity

Objective — to increase the effectiveness of treatment of nonspecific vaginitis in menopausal women with excess body weight and obesity through long-term lifestyle modification. Materials and methods. 1178 patients aged 45—55 years were examined, including 317 with nonspecific vaginitis, who were divided into 3 study groups: with a healthy body weight, overweight and obesity. Each group was divided into three subgroups of comparison with standard therapy and three study groups that applied long-term lifestyle modification (actively and systematically used behavioral therapy, physical activity and a low-calorie diet) for 6 months. The control group consisted of 72 volunteers. Results and discussion. In the study subgroups of women who used long-term lifestyle modification, recurrences of nonspecific vaginitis were less frequent than in the corresponding comparison subgroups. Thus, after 6 months, in subgroups of women with a healthy body weight, the difference in the frequency of relapses after treatment was 40 % greater (34.2 vs 20.5 %), with excess body weight — 31.1 % (41.2 vs 28.4 %), with obesity — 29.8 % (55.1 vs 38.7 %). A significant deterioration in the state of the microbiota in menopausal patients with increased body weight and the effectiveness of the use of long-term lifestyle modification on its condition were established. It was proven that excess body weight and obesity in women negatively affected the frequency of nonspecific vaginitis, clinical picture, decreased quality of life, and frequency of relapses. Active and systematic use of behavioral therapy, physical activity, and a low-calorie diet in patients with nonspecific vaginitis in menopause had significant advantages in preventing relapses, compared to standard therapy, and in preserving and improving the quality of life of obese patients. Conclusions. Overweight and obese women are more likely than healthy women to suffer from nonspecific vaginitis, which is more severe and recurrent, accompanied by a decrease in quality of life and a disruption of the vaginal and skin biotope. After 6 months in obese postmenopausal women, the use of long-term lifestyle modification contributes to the restoration of the vaginal and skin microbiome, a decrease in the frequency of recurrences of nonspecific vaginitis and an improvement in quality of life compared with subgroups. with standard therapy. The best effect of treatment was observed in women with a healthy body weight, and the worst in the presence of obesity.

Predictive value of CA-153, CA-125 and Apo A for ocular metastasis in menopausal female patients with breast cancer.

To establish a meaningful standard for diagnosing ocular metastasis (OM) in menopausal breast cancer (BC) women, and explore the relationship between CA-153, CA-125, apolipoprotein A, and OM. A total of 1362 menopausal female BC patients with OM volunteered to take part in this study between July 2012 and July 2022. Women with BC who are menopausal were found to have an OM incidence of 1.6%. Furthermore, CA-153, CA-125, and apolipoprotein A (Apo A) all contributed to OM in women with BC who are postmenopausal according to binary logistic regression. Receiver operating curve (ROC) analysis was used to assess the diagnostic value of OM in patients with BC. Both CA-153 and CA-153+CA-125 showed a higher sensitivity of 95.45%, whereas CA-153+Apo A illustrated the highest specificity of 99.02%. Moreover, CA-153 and CA-153+CA-125 had higher areas under the curve (AUC) of 0.973. The data indicate that the serum concentrations of CA-153 exhibited the most significant predictors of the diagnosis of OM in menopausal women with BC. The current study researches the utility of risk factors in predicting of OM in menopausal BC women and put forward the latest suggestions on their clinical application.

Evaluation of the relationship between types of menopause and cognitive function.

Menopause is often accompanied by neurological symptoms, including cognitive difficulties, especially with memory and attention. The purpose of the present study was to examine the relationship between the timing of menopause and the cognitive performance of menopausal patients who applied to our neurology clinic with complaints of forgetfulness. The data of 538 women who applied to the neurology clinic with complaints of forgetfulness between January 2018 and January 2024 and underwent neuropsychological evaluations were scanned retrospectively. A total of 96 patients who applied to the neurology and menopause clinics were included in the study. The attention orientation, verbal fluency, memory, and total Addenbrooke's cognitive evaluation battery-revised (ACE-R) test scores were significantly higher in the >50-year-old menopausal group when compared to the other groups (p < 0.001). A statistically significant, negative, and weak relationship was detected between the body mass index (BMI) and memory scores (r = 0.3, p < 0.001). A statistically significant, positive, and weak relationship was detected between the high-density lipoprotein level and verbal fluency score, memory score and ACE-R score (r = 0.3, p < 0.001). A statistically significant, negative, and weak relationship was detected between the BMI and memory scores (r = 0.3, p < 0.001). The relationship between the cognitive performance of menopausal women and the timing of menopause was examined herein. The ACE-R, attention and orientation, visual, verbal fluency, and memory scores were significantly higher in women ≥50 years of age who entered menopause compared to those <40 years of age and those between 40 and 50 years of age. This study provides evidence that advancing age at menopause is associated with better cognitive performance. This relationship is most evident in the areas of the attention, verbal fluency, memory, and visuospatial domains.

Prevalence of Endometriosis in Postmenopausal Women: A Systematic Review

Introduction: Endometriosis is generally known as a condition that occurs in reproductive-age women, but cases in menopausal women have also been reported, especially in those who have received postmenopausal hormone therapy. The prevalence of endometriosis in menopausal women can reach 2.2% of all diagnosed cases of endometriosis. Material and Methods: There are 4 articles included from 3 databases. Several databases used included PubMed, ScienceDirect, and Taylor &amp; Francis. The sample population included postmenopausal patients with endometriosis. Exclusion criteria included non-peer-reviewed journals, non-human research study designs, and grey literature. 4 articles are showing that endometriosis can occur in postmenopausal women. The articles show that the prevalence of endometriosis in postmenopausal women is around 2-20% where the diagnosis is made based on a combination of laparoscopic visualization and histological confirmation. Results: The occurrence of endometriosis in postmenopausal women can occur due to various risk factors, including the use of hormone replacement therapy (HRT) and obesity because it can increase estrogen levels, which results in the development of endometriosis. Therefore, it is important to recognize that endometriosis is not only limited to women of productive age but can also occur in those who have passed menopause because they are often suspected of being malignant. Conclusion: In general, patients with endometriosis have a higher risk of developing ovarian cancer. But, the clinical picture of endometriosis in menopausal patients is nonspecific. This makes endometriosis often experience a delay in diagnosis, especially in elderly patients. Postmenopausal women with endometriosis should be treated with surgery.

Efficacy of Non-cross Linked Hyaluronic Acid Injection versus Platelet Rich Plasma Injection in Treatment of Sexual Dysfunction Caused by Vulvo-vaginal Atrophy in Post-menopausal Females and Their Impact on Sexual Satisfaction

Abstract Background Sexuality in women is a relatively new field of bio-medical research. The prevalence of female sexual dysfunction among postmenopausal women approaches 50% with vulvovaginal atrophy being a cardinal sign in most post females among this age group. For decades hormone replacement therapy was the only solution to get rid of symptoms associated with this atrophy. However, hormone replacement therapy was limited by its serious side effects, raising the need for new treatment strategies with less side effects. Objectives The aim of this study is to compare between the efficacy and safety of non-cross linked hyaluronic acid injection (HA) versus autologous platelet rich plasma (PRP) injection into the vagina and labia majora of post- menopausal females presented with vulvo-vaginal atrophy to improve female sexual dysfunction. Methods Twenty post menopausal female patients presenting with vulvovaginal atrophy were enrolled in this study. Patients were randomly divided into two groups, 10 patients in each group. The first group received non cross linked hyaluronic acid injection into the labia majora and the vagina, however the second group received platelets rich plasma injections in the same sites as the first group. Subjective assessment was carried out in the form of female sexual function index questionnaire, female sexual distress scale revised questionnaire, index of sexual satisfaction for the female and male partner and global aesthetic improvement scale. Objective assessment was carried out by measuring the labia majora length and reviewing the histopathological changes occurring in the vulva through skin biopsies taken before and after treatment. Estimating the change in vaginal was thickness was done through performing transvaginal ultrasound. Results Non cross linked hyaluronic acid as well as PRP were found to be effective and safe in the treatment of post menopausal vulvovaginal atrophy. However, HA showed more significant improvement in female sexual function index (P &amp;lt; 0.01) and significantly higher couple satisfaction as assessed by index of sexual satisfaction (P &amp;lt; 0.05). There was also higher values in vaginal wall thickness as measured by transvaginal ultrasound in favor of HA injected group. Histopathological assessment showed more changes in papillary dermis in HA treated group. No complications were reported in both groups Conclusion There was a great need for non hormonal therapies for post menopausal females. Both non cross linked hyaluronic acid and PRP were effective in relieving symptoms of vulvovaginal atrophy. However, non cross linked hyaluronic acid showed more patient and over all couple satisfaction. It also showed more improvement in histopathology and ultrasound assessments.

Influence of the Onset of Menopause on the Risk of Developing Alzheimer's Disease.

Menopause is a natural phase marked by the permanent cessation of menstrual cycles, occurring when the production of reproductive hormones from the ovaries stops for at least 12 consecutive months. Studies have suggested a potential connection between menopause and a heightened risk of developing Alzheimer's disease (AD), underscoring the significant role of reduced estrogen levels in the development of AD. Estrogen plays a crucial role in brain metabolism, influencing energy metabolism, synaptic plasticity, and cognitive functions. The cognitive benefits associated with hormone replacement therapy (HRT) are believed to be linked to estrogen's neuroprotective effects, either through direct action on the brain or indirectly by improving cardiovascular health. Extensive literature supports the positive impact of estrogen on brain cells. While the physiological effects of estrogen on the brain have not been consistently replicated in clinical trials, further research is crucial to provide more definitive recommendations to menopausal patients regarding the influence of HRT on AD. This review aims to comprehensively explore the interplay between menopause and AD, as well as the potential of HRT to mitigate cognitive decline in post-menopausal individuals.

Age-related characteristics of the content and activity of certain components of the blood fibrinolytic system in cases of uterine cancer

Uterine cancer (UC) is the third most common cancer in women in Russia. Knowledge of age-specific features of the fibrinolytic system in patients with UC can be useful in terms of improving its pathogenetic therapy. Aim of the study was to investigate the peculiarities of the content and activity of some components of the fibrinolytic system in the blood of UC patients of different age groups. Material and methods. 30 healthy women (donors) and 56 patients with uterine cancer T1a-2N0M0, adenocarcinoma G1–G3 were divided into subgroups according to age: reproductive, perimenopause and menopause. ELISA of urokinase (u-PA), its receptor (u-PAR) and its inhibitor (PAI-1), tissue-type plasminogen activator (t-PA) content were performed in blood collected before treatment. Results. In reproductive UC patients, inhibitor u-PA (PAI-1) activity increased 14-fold (hereinafter the difference is statistically significant, p &lt; 0.05) and content increased 2.9-fold, while receptor u-PA (u-PAR) level decreased 1.7-fold compared to reproductive donors. Perimenopausal UC patients showed a 3.3-fold increase in PAI-1 content and a 6.3-fold increase in PAI-1 activity compared to perimenopausal donors, t-PA concentration decreased 1.3-fold relative to donors and was 1.9-fold lower than in reproductive UC patients. In menopausal patients with UC, the activity and content of PAI-1 enhanced 5.5-fold and 4.5-fold, respectively, compared to donors. Additionally, they were 2.1-fold and 1.2-fold lower than in reproductive UC patients. The activity of u-PA increased 2.6-fold, reaching the values of reproductive UC patients. The activity of t-PA was 1.3-fold higher than in donors, but did not differ from the activity in other RTM patients, while the level of t-PA occupied an intermediate position between the corresponding indices in young UC patients (it was 1.4-fold lower) and perimenopausal UC patients (it was 1.4-fold higher). Conclusions. The development of UC is accompanied by an imbalance of components of the fibrinolytic system in the blood, depending on the age of women, with a minimum spectrum of changes in the indicators in reproductive patients and maximum - in menopause patients, which indicates the pathognomonicity of these factors in PTM and requires an individual approach to the management of such patients.

Effect of Menopausal Hormone Therapy on Cellular Immunity Parameters and Cytokine Profile.

A woman's entry into the menopause period is associated with a number of changes in the body, including those related to the immune system. Immune aging is a consequence of age-related changes in the function of immune cells and the composition of their subpopulations. Menopausal hormone therapy (MHT) is thought to partially neutralize the negative effects of aging on the immune system. We aimed to evaluate the effect of oral and transdermal MHT on cellular immunity parameters and cytokine profile in menopausal women. Fifty peri- and early postmenopausal women were included. Immune parameters were assessed by flow cytometry and multiplex analysis. We showed that different routes of MHT administration led to significant changes in monocyte phenotype and a decrease in monocyte chemoattractant protein-1 (MCP-1) level in menopausal patients. In addition, oral MHT resulted in a significant increase in NK and B cells. A significant increase in the number of T-helper cells was observed with transdermal MHT. In addition, oral MHT resulted in a significant decrease in IL-1β level. We have demonstrated for the first time that oral therapy, in contrast to transdermal therapy, has a more pronounced effect on specific immune subpopulations of blood cells in menopausal women. This effect is likely to be responsible for its anti-aging properties in the context of immune aging as well as its protective effects in infectious diseases. Perhaps testing blood immune parameters or assessing immune status before prescribing MHT could become a routine step in clinical practice before choosing a patient management strategy.

The Association of Systemic and Mandibular Bone Mineral Density in Postmenopausal Females with Osteoporosis.

Background/Objectives: Osteoporosis is a common general disease that mostly affects the skeletal system, including the jawbone. There is a link between systemic and mandibular osteoporosis. This study aimed at assessing the association between systemic (lumbar spine L1-L4, femoral neck, total hip) bone mineral density (BMD) and mandible BMD sites in Romanian postmenopausal females. Methods: A total of 97 menopausal patients were studied, 62 with osteoporosis and 35 females with no osteoporosis. For each patient, dual-energy X-ray absorptiometry (DXA) assessments of BMD in the mandible, proximal femur, total hip, and lumbar spine (L1-L4) were performed. Mandibular measurements were performed using the distal forearm software, followed by manual analysis after the bone contour was defined in each case. Results: Comparing the osteoporosis and control groups, there were significant differences in BMD at each examined location. The mandibular BMD (1.125 ± 0.181506 g/cm2) in the osteoporosis group was considerably smaller than in the control group (1.35497 ± 0.244397 g/cm2). Correlations between the BMD at different sites were significant: lumbar spine and femoral neck (r = 0.738, p < 0.0001), lumbar spine and total hip (r = 0.735, p < 0.0001), lumbar spine and mandible (r = 0.506, p < 0.0001), femoral neck and total hip (r = 0.891, p < 0.0001), femoral neck and mandible (r = 0.482, p < 0.0001), and total hip and mandible (r = 0.466, p < 0.0001). Conclusions: There were correlations between mandible BMD and lumbar spine, femoral neck, and total hip BMD, suggesting that osteoporosis affects mandibular bone density. BMD assessments at common locations may help predict mandibular BMD and the probability of osteoporosis.

(195) QUANTITATIVE SENSORY TESTING OF THE CLITORIS, VULVA AND VESTIBULE IN MENOPAUSAL PATIENTS WITH SEXUAL DYSFUNCTION

Abstract Introduction Individuals in menopause often complain of sexual dysfunction (low libido, reduced sensation, muted orgasm). In sexual-health related menopause concerns, hormonal pathophysiologies have been well studied. However, the effects of menopause on the integrity of the female genital sensory pathways have not been well researched. There is one report of reduced vulvar sensitivity with menopause in the literature. Somatic afferent pathways of the clitoris, vulva and vestibule include the dorsal and perineal nerve branches of the pudendal nerve (S2-S4). To assess the integrity of these somatic afferent pathways, genital quantitative sensory testing (QST) may be performed. QST consists of vibration perception threshold testing for large myelinated A-beta fibers and temperature perception threshold testing for small myelinated A-delta fibers (cold) and for unmyelinated c-fibers (warm). Objective We wished to assess genital QST in 2 cohorts of menopausal patients with sexual dysfunction. Methods This is a chart review of menopausal patients presenting to a sexual medicine clinic for sexual dysfunction between January 2022 and May 2024. They all presented with limited or no previous menopause management by systemic and/or local sex steroid hormone treatment. The patient cohort was divided into those with genitourinary syndrome of menopause (GSM) alone where neurologic disease is not obvious, and those with persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD), a disease state in which neurologic disease is well documented. Quantitative sensory testing of vibratory, cold and warm sensation was performed at their initial visit, prior to any treatment from our clinic, using a biothesiometer (Bio-Medical Instruments, Newbury, OH) to test for vibration perception threshold (VPT) measured in volts, and a thermal sensitivity tester (Sensortek, Inc., Clifton, NJ) to test for cold perception threshold (CPT) and warmth perception threshold (WPT) measured in degrees Centigrade, comparing the genital readings to a non-genital location as control. Abnormal QST was defined when the test value was ≥2 standard deviations from the control value. Results A total of 30 charts of patients in menopause were reviewed. Sixteen individuals, mean age 59 (range 50 to 81 years), presented for GSM alone. Abnormal VPT testing was found in 63%, mean VPT value 15 V compared to 6 V for control. Abnormal CPT testing was found in 44%, mean CPT value 19°C compared to 22°C for control. Abnormal WPT testing was found in 68%, mean WPT value 35°C compared to 27°C for control. Fourteen individuals, mean age 64 (range 50 to 78 years), presented with concomitant PGAD/GPD. Abnormal VPT testing was found in 71%, mean VPT value 16 V compared to 5 V for control. Abnormal CPT testing was found in 43%, mean CPT value 20°C compared to 22°C for control. Abnormal WPT testing was found in 71%, mean WPT value 35°C compared to 28°C for control. Conclusions A similar prevalence was found of abnormal QST testing in 44%-68% and 43% - 71%, respectively, of menopausal individuals without and with PGAD/GPD. We conclude that genital sensory impairment is common in menopause, may contribute to menopause-related sexual dysfunction, and should be documented objectively by baseline neurogenital testing. Disclosure No.

Injectable Biomimetic Hydrogel Constructs for Cell-Based Menopausal Hormone Therapy with Reduced Breast Cancer Potential.

Hormone replacement therapy (HRT) has been a primary method in menopausal women and patients with ablated ovaries, but safety has been a concern. Cell-based HRT has emerged as an alternative approach without side effects causing pharmaceutical HRT via 3-dimensionally engineered constructs layering ovarian hormone-producing cells. In this study, we applied micro-sized ovarian cell-laden hydrogel beads as an approach to cell-based HRT using a minimally invasive method in the menopausal rat model. Here, we constructed GC/TC-laden microbeads (GTBs; GC, granulosa cell; TC, theca cell) that allow crosstalk between endocrine cells, encapsulating multiple beads for the figuration of the original ovary. We assessed the ovarian hormone production function of GTB through invitro culture for 90 days. We applied it to a menopausal rat model and confirmed that GTB-injected rats restored their endocrine function, leading to the regeneration of the thinned endometrium and the maintenance of regular estrous cycles in some individuals. Additionally, it was observed to alleviate menopausal symptoms, including body weight gain and osteoporosis. Notably, the GTB-injected rats did not show mammary gland hyperplasia observed in the pharmaceutical HRT groups and exhibited fewer p53- and KI67-positive and an increase in phosphatase and tensin homolog-positive mammary gland epithelial cells compared to pharmaceutical hormone-treated rats. These results suggest that GTB-based HRT could present a lower risk of breast cancer compared to conventional pharmaceutical-HRT use. Our study highlights the potential of cell-based HRT using an injectable artificial ovary, offering a safer alternative for women requiring HRT.

Behavioral Therapy in Post Menopause Patients with Urine Incontinence Problems – Systematic Review

A journal search was carried out used the keywords "Postmenopausal women AND Cognitive Behavioral therapy AND urinary incontinence AND meta analysis" to collect relevant articles published in the last 10 years from five databases (ProQuest, PubMed, Science Direct, Ebsco and Google Scholar. Criteria inclusions were: nurses, patients, urinary incontinence, intervention, full text articles, studies that focused on nursing assessment, and written in English. Six journal articles were selected and analyzed using PICO. Results, Non-pharmacological therapy with a behavioral therapy approach with the application of MBSR (Mindfulness based stress reduction) and HEP (Health Enhancement program) as well as Yoga Therapy &amp; PFMT (Pelvic Floor Muscle Training) exercises combined with light physical exercise such as walking, cycling, swimming. for 30 minutes as well as diet modifications can help postmenopausal patients with urinary incontinence. Conclusion: The application of MBSR (Mindfulness based stress reduction) and HEP (Health Enhancement program) as well as Yoga Therapy &amp; PFMT (Pelvic Floor Muscle Training) exercises combined with light physical exercise such as walking, cycling, swimming for 30 minutes and diet modification can reduces the number of episodes of urine leakage and improves all types of urinary incontinence problems as well as quality of life and can be beneficial for sexual function in post menopausal women.

Peculiarities of management of patients in menopause from the point of view of a family doctor

Menopause is a difficult period in a woman’s life when her body needs support. In cases where hormonal therapy is contraindicated, which is not uncommon, it is necessary to resort to prescribing herbal preparations, which are quite effective and at the same time have no contraindications. One of these drugs is Menomedin®-M, which can be prescribed by both obstetrician-gynecologists and general practitioners. The composition, mechanism of action, therapeutic effects and results of clinical studies of plant components of Menomedin®-M ensure the effectiveness of prescribing this phytocomplex for women with climacteric syndrome

P-422 Modified natural cycle does not increase live birth rates compared to hormone replacement therapy: success rates and perinatal outcomes of 1.354 single euploid blastocyst cryotransfers

Abstract Study question Frozen euploid single blastocyst transfer in modified natural cycle (mNC) increases success rates, improving obstetric outcomes compared to hormone replacement therapy (HRT) protocols? Summary answer Elective euploid single-blastocyst transfer (eeSBT) in mNC did not show higher success rates nor better obstetric and perinatal outcomes compared to HRT protocols What is known already eeSBT has become the gold standard for clinical trials in assisted reproduction, increasing sample homogeneity and reducing bias; when choosing endometrial preparation protocols for thawed embryo transfers, recent clinical studies have reported the superiority of mNC over HRT in terms of delivery and miscarriage rates, obstetrical and perinatal outcomes, treatment safety and costs; however, few data are available on eeSBT ≥3BB (Gardner score) cryotransfers comparing both protocols Study design, size, duration Retrospective single-centre comparative clinical study, including 1.354 eeSBT (≥3BB, Gardner score) between Jan-2018 and Dec-2022: 1.109 (82%) in HRT and 245 (18%) in mNC. HRT and mNC groups were homogeneous for egg donor’s age (28,9±5,8 yo Vs 30,6±5,9 yo), recipient’s age (41,7±5,0 yo Vs 39,5±4,5 yo), body mass index (22,6±4,8 Vs 23,1±3,4) severe male factor (3,5% Vs 7,3%), the need for sperm donation (30,4% Vs 27,8%), and the average throphoectoderm embryo quality (A = 32,1% Vs A = 31,8%) Participants/materials, setting, methods We studied the clinical, obstetric and perinatal outcomes of the 1.354 eeSBT performed, comparing HRT and mNC cycles for: pregnancy rate, miscarriage rate, live birth rate, twin pregnancy rate, severe preeclampsia, preterm birth rate (&amp;lt;37, &amp;lt;35, &amp;lt;32 and &amp;lt;28 weeks) and neonatal weight. We used Chi-square test to compare groups (p &amp;lt; 0,05). Main results and the role of chance There were no statistically significant differences between HRT Vs mNC protocol when comparing pregnancy rates (63,8% Vs 62,0%, p = 0,61), miscarriage rates (15,3% Vs 15,8%, p = 0,87) and live birth rates (44,6% Vs 46,1%, p = 0,67). The were no twin pregnancies in the mNC group, and only 5 (1%) in the HRT group. There we no significant differences in the severe preeclampsia rate, even if it doubled in the HRT group compared to mNC (1,8% Vs 0,9%, p = 0,48). Preterm, major and extreme preterm birth rates were higher in HRT but comprable to the mNC group: &amp;lt;37 weeks (7,7% Vs 6,2%, p = 0.59) &amp;lt; 35 weeks (2,8% Vs 1,8%, p = 0,59) &amp;lt;32 weeks (1,2% Vs 0,9%, p = 0,77) &amp;lt;28 weeks (0,4% Vs 0,9%, p = 0,51). There were no significant differences in neonatal weight (3287 + 477g HRT Vs 3271 + 512g in mNC, p = 0,88). Limitations, reasons for caution The HRT group included 84 patients in menopause (confounding factor), but when excluding them in a preliminary study results didn’t change. We decided to include eeSBT both from egg donation and own patient’s egg IVF treatments, after verifying that there were no significant differences in clinical results between both groups. Wider implications of the findings In eeSBT, the use of modified natural cycle could be encouraged because of its better cost-effectivenes and patient’s comfort. This study reports a non-significant trend for higher success rates in mNC compared to HRT; further prospective trials should be promoted to give accurate advice to patients undergoing thawed embryo transfers. Trial registration number Not Applicable

O-060 Ovarian rejuvenation - fact or fiction?

Abstract Ovarian aging is a reality and a physiological process which occurs with age resulting in to premature depletion of eggs . POI occurs in approximately 1% of the women who have not reached 40 years of age. The frequency is roughly 4–8% in women experiencing secondary amenorrhea and 10–28% in cases of primary amenorrhea .The prevalence of POI was higher in countries with medium and low human development indexes . . We analysed 1000 infertile patients of less than 40 years . 110 patients had AFC less then 2 and opted for egg donor program . cycle cancellation was due to nonavailability of eggs on OPU was seen in 4% cases in our analysis . Presence of oogonial stem cells (OSCs) in the ovarian cortex , hinting at a possibility of therapeutic stimulation of post-natal folliculogenesis in subfertile women it is postulated that ovarian aging or insufficiency could be reversed if OSCs are provided a healthy environment. Ovarian rejuvenation therapy is a new and innovative approach to enhancing fertility in this group of patients . It is often carried out using platelet-rich plasma (PRP) or stem cell therapy. Ovarian Rejuvenation with Stem cells is also called Autologous Stem Cell Transplant in the Ovary (ASCOT). PRP is having lots of advantages like therapeutic effect, cost effectiveness, ease of isolation and autologous nature. However some drawbacks are also there like inconclusive efficacy and lack of understanding of mechanism of action, lack of RCT /fundamental research . regenerative processes organized by platelet cytokines in somatic cells are poorly understood . PRP infusion may only be an appropriate treatment for select ovarian disorders. perimenopausal women and women deemed to be POR benefitted the most from the treatment, more so than POI and menopausal patients . platelet cytokines are ligands that attach to cell membrane receptors—not the nucleus . no case of tumorogenic activity observed in any clinical context so far . Further reassurance comes from work in other human tissue treated with PRP, where accelerated growth of healthy cells was noted without triggering malignant transformation . 13 registered clinical trials investigating the effect of PRP on ovarian rejuvenation .few of these trials describe the inclusion of appropriate PRP controls. It is only from well-controlled trials, built on detailed mechanistic understanding that we can clarify the platelet-mediated effects of PRP therapy in ovarian rejuvenation and folliculogenesis. The PRP injections into the ovaries are safe, productive, and a natural treatment that may help women with premature ovarian insufficiency to give birth to their own child . Stem cell therapy is attracting attention in the field of regenerative medicine and is advancing rapidly. Many recent studies have applied stem cell therapy to treat reproductive system diseases; however, data are not yet available as to whether this therapy shows enhanced therapeutic effects. It is evident that stem cell therapies have potential in treating POI. Stem cells and their exosomes, including content such as miRNAs, show positive effects in enhancing and restoring various aspects of ovarian function, such as folliculogenesis, the GC apoptosis rate, vascular formation, and genetic stability. Among the 10 clinical trials in the NIH database, only 4 have been completed; the rest are ongoing, recruiting and/or active. Research subjects have been selected by strict standards. Although there are several active ongoing clinical trials for POI using stem cell-based therapeutics, there are restrictions in each country regarding ethical and clinical concerns from the health-care community .Potential of stem cell therapies in treating POI still needs further research and clinical results.

P-643 Menopause should not be considered a confounding factor in endometrial preparation protocol’s comparative clinical trials: a retrospective cohort study with 1.109 euploid single embryo transfers

Abstract Study question Does menopause have an impact on obstetric and perinatal outcomes when performing elective euploid single-blastocyst transfers (eeSBT) in a hormonal replacement treatment (HRT) protocol? Summary answer eeSBT in a non-menopause elective HRT group(eHRT) did not show higher success rates nor better obstetric and perinatal outcomes compared to a menopause HRT group(mHRT). What is known already Menopause has been suggested to be a confounding factor in clinical trials when comparing the results and success rates for endometrial preparation in modified natural cycle (mNC) Vs HRT: including menopause patients could lead to selection bias seen that they can never be included in the mNC group. Few data are available on eeSBT ≥3BB (Gardner score) cryotransfers comparing obstetric and perinatal results between eHRT and mHRT, to have the opportunity to include them all in further comparative trials, with a low bias risk. Study design, size, duration Retrospective single-centre comparative study, including 1.109 eeSBT (≥3BB, Gardner score) between Jan-2018 and Dec-2022: 1.025 (92,4%) in eHRT and 84 (7,6%) in mHRT. The eHRT and mHRT groups were homogeneous for egg donor’s age (29,1±5,9 yo Vs 25,8±4,1 yo) recipient’s age (41,4±4,9 yo Vs 44,9±4,7 yo), body mass index (22,6±4,7 Vs 22,6±5,3) severe male factor (3,5% Vs 3,6%), the need for sperm donation (30,0% Vs 35,7%), and the average throphoectoderm embryo quality (A = 32,5% Vs A = 29,8%). Participants/materials, setting, methods We studied the clinical, obstetric and perinatal outcomes of the 1.109 eeSBT, comparing eHRT and mHRT groups for: pregnancy rate, miscarriage rate, live birth rate, twin pregnancy rate, severe preeclampsia, preterm birth rate (&amp;lt;37, &amp;lt;35, &amp;lt;32 and &amp;lt;28 weeks) and neonatal weight. We used Chi-square test and T-Test to compare groups (p &amp;lt; 0,05). Main results and the role of chance There were no statistically significant differences between eHRT and mHRT groups when comparing pregnancy rates (63,7% Vs 64,3%, p = 0,92), miscarriage rates (15,6% Vs 11,1%, p = 0,053) and live birth rates (44,3% Vs 48,8%, p = 0,42); no significant differences were found in the severe preeclampsia rate(2,0 Vs 1,2, p = 0,84), nor in the twin pregnancy rate (0,9 Vs 2,4, p = 0,34) even if it almost tripled in the mHRT group. Preterm, major and extreme preterm birth rates were comprable between eHRT and mHRT groups: &amp;lt;37 weeks (9,9% Vs 4,9%, p = 0,29) &amp;lt; 35 weeks (3,3% Vs 0, p = 0,23) &amp;lt;32 weeks (1,3% Vs 0, p = 0,46) &amp;lt;28 weeks (0,2% Vs 0, p = 0,76). There were no significant differences in neonatal weight (3292 + 481g Vs 3.135 + 419g, p = 0,052). Limitations, reasons for caution In a preliminary study, we compared and additional 245 eeSBT in mNC with the HRT group, and no significant differences in obstetric or perinatal outcomes were reported when including or excluding the mHRT sub-group. Wider implications of the findings In eeSBT, the eHRT group did not report better obstetric nor perinatal results compared to the mHRT group; further prospective clinical trials comparing mNC Vs HRT should not consider menopause as a major confouding factor, when using eeSBT. Trial registration number Not Applicable

Risk factors for residual lesions after total hysterectomy in patients with high-grade cervical intraepithelial neoplasia

BackgroundThe purpose of this study was to predict the risk factors for residual lesions in patients with high-grade cervical intraepithelial neoplasia who underwent total hysterectomy.MethodsThis retrospective study included 212 patients with histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2-3) who underwent hysterectomy within 6 months after loop electrosurgical excision procedure (LEEP). Clinical data (e.g., age, menopausal status, HPV type, and Liquid-based cytology test(LCT) type), as well as pathological data affiliated with endocervical curettage (ECC), colposcopy, LEEP and hysterectomy, were retrieved from medical records. A logistic regression model was applied to estimate the relationship between the variables and risk of residual lesions after hysterectomy.ResultsOverall, 75 (35.4%) patients had residual lesions after hysterectomy. Univariate analyses revealed that positive margin (p = 0.003), glandular involvement (p = 0.017), positive ECC (p < 0.01), HPV16/18 infection (p = 0.032) and vaginal intraepithelial neoplasia (VaIN) I-III (p = 0.014) were factors related to the presence of residual lesions after hysterectomy. Conversely, postmenopausal status, age ≥ 50 years, ≤ 30 days from LEEP to hysterectomy, and LCT type were not risk factors for residual lesions. A positive margin (p = 0.025) and positive ECC (HSIL) (p < 0.001) were identified as independent risk factors for residual lesions in multivariate analysis.ConclusionsOur study revealed that positive incisal margins and ECC (≥ CIN2) were risk factors for residual lesions, while glandular involvement and VaIN were protective factors. In later clinical work, colposcopic pathology revealed that glandular involvement was associated with a reduced risk of residual uterine lesions. 60% of the patients with residual uterine lesions were menopausal patients, and all patients with carcinoma in situ in this study were menopausal patients. Therefore, total hysterectomy may be a better choice for treating CIN in menopausal patients with positive margins and positive ECC.

(070) SUCCESSFUL TREATMENT OF NEUROPROLIFERATIVE VESTIBULODYNIA IN MENOPAUSAL PATIENTS

Abstract Introduction As pain symptoms from neuroproliferative vestibulodynia (NPV) often arise at initial attempt at tampon insertion or penetrative sex, most vestibulodynia patients present in their 20’s or 30’s. Consequently, individuals who reached this age prior to 2004-when Dr. Bornstein and colleagues delineated the excess mast cell and nerve pathology-had limited opportunity for successful NPV diagnosis and treatment. Menopausal patients often experience vulvar pain with genitourinary syndrome of menopause (GSM) due to the paucity of sex steroid hormonal support of their genital tissues. While symptoms of painful penetration are similar in both of these conditions, NPV is diagnosed when severe allodynia/hyperalgesia is still present with a normal or corrected hormonal milieu. A treatment for NPV is complete vestibulectomy surgery, performed in premenopausal eugonadal patients. However, in hormonally depleted patients with GSM, the vaginal tissue is thinner and less robust making it less optimal for reconstructive surgery. Objective To examine the intersection of genitourinary syndrome of menopause and neuroproliferative vestibulodynia symptoms in a subgroup of at-risk patients and to report techniques for optimizing management of this patient population. Methods We reviewed charts of two menopausal patients with NPV and report a clinical strategy for successful management. Results Two patients, ages 58 and 63 reported histories consistent with NPV during their reproductive years-one with lifelong entrance pain with any insertion and one with pain-free penetration prior to experiencing severe burning upon use of topical miconazole for candidiasis. At presentation, both had entry pain symptoms consistent with GSM and NPV. Since NPV is a diagnosis of exclusion, each was treated for GSM with intravaginal DHEA and vestibular topical compounded testosterone/estradiol cream. After 6 months, vestibular pallor and erythema resolved, however, cotton-tip swab testing scores did not improve. A positive improvement with vestibular anesthesia testing was consistent with NPV. Each underwent a complete vestibulectomy with vaginal advancement flap with successful wound healing and no adverse events despite their age and prior GSM diagnosis. Both patients report “very much better” symptoms on post-op Patient Global Impression of Improvement. Immunohistochemical staining of excised vestibular tissue confirmed a high density of CD117 and PGP9.5 staining consistent with an NPV diagnosis. Each patient has continued their menopause treatments post-op. Conclusions We report on two menopausal patients with NPV who had classic symptoms of severe allodynia/hyperalgesia in their reproductive years but who were not managed as NPV patients due to lack of knowledge at that time. Treating the GSM first with hormone replacement may restore health to vaginal tissues, thereby allowing the excised vestibular region to be covered with a vaginal advancement flap. Managing GSM symptoms prior and then undergoing vestibulectomy allowed them to have pain-free penetration. Disclosure No.

(098) LOW INTENSITY SHOCKWAVE THERAPY FOR WOMEN WITH SEXUAL DYSFUNCTION

Abstract Introduction Low intensity shockwave therapy (LiSWT) has been used to treat sexual dysfunction by inducing genital tissue mechanotransduction. Mechanotransduction is the ability of a cell to actively convert contraction/expansion mechanical stimuli induced by exposure to the shockwave energy into biochemical signals with physiological effects including synthesis of nitic oxide, upregulation of vascular endothelial growth factors, recruitment of endothelial progenitor cells, vasodilation, and expression of tumor necrosis factor alpha mRNA with anti-inflammatory activity. The greater the shockwave energy absorbed in genital tissues, the greater the opportunity for mechanotransduction physiologic effects to occur and improve sexual function. Therefore, effectiveness of LiSWT depends, in part, on applied energy (mJ/mm2) and number of applications (total shocks). In 2019, our sexual medicine clinic began utilizing the SoftWave (Urogold 100™) LiSWT device, FDA cleared for pain amelioration, connective tissue activation, wound healing, and improved blood flow, to treat individuals with vulvas with sexual dysfunction. Objective To review the various sexual health concerns in individuals with vulvas effectively treated by LiSWT. Methods A chart review was performed of individuals with vulvas with various sexual dysfunctions, including genital pain and genito-pelvic dysesthesia (GPD), who received LiSWT between April 2019 and June 2023. In general, 2400 shocks were applied at energy flux density 0.05-0.08 mJ/mm2, Hz = 3, membrane pressure = 1. The Patient Global Impression of Improvement (PGI-I) was used to assess post-LiSWT outcome; improvement was positive if the post-LiSWT PGI-I ranged from 1-3. Results 189 women, mean age 32 (range 18–67) years, with sexual dysfunction underwent LiSWT treatments in the 38 months. 18 women with neuroproliferative vestibulodynia (NPV) who underwent vestibulectomy received 3-6 post-operative vestibular LiSWT to reduce post-operative pain and improve wound healing; 83% reported improved PGI-I. 24 patients with hormone-mediated vestibulodynia who elected not to use hormone treatment, underwent vestibular LiSWT; 54% reported improved PGI-I. 25 menopausal patients with persistent symptoms of Genito-Urinary Syndrome of Menopause (GSM) received multiple vestibular LiSWT treatments; 64% improved PGI-I, including reduction of urinary incontinence. 36 women with PGAD/GPD from lumbosacral annular tear-and/or Tarlov cyst-induced sacral radiculopathy who were not candidates for minimally invasive spine surgery or continued to have symptoms after recovering from spine surgery, underwent multiple treatments of lumbosacral spine LiSWT; 58% reported improved PGI-I. 86 patients with neuroproliferative vestibulodynia (NPV) underwent 2-3 pre-operative sessions of vestibular LiSWT immediately prior to complete subepithelial vestibulectomy surgery; they used significantly fewer opioids post-op than those without pre-operative LiSWT based on historical data prior to 2019. All patients received multiple LiSWT sessions to maximize mechanotransduction effects on genital tissues. There were no significant adverse events noted with LiSWT use. Conclusions Multiple LiSWT sessions are utilized in individuals with vulvas with sexual dysfunction to maximize mechanotransduction. LiSWT is associated with improved sexual health symptoms ranging from 54% - 75%, not associated with any side effects. More research is needed regarding the role of LiSWT for management of various sexual dysfunctions. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Softwave TRT.