To date, there remains a paucity of prospective studies examining the association between premature ovarian insufficiency (POI) and cardiovascular diseases (CVD). The objective of this study was to investigate the potent...To date, there remains a paucity of prospective studies examining the association between premature ovarian insufficiency (POI) and cardiovascular diseases (CVD). The objective of this study was to investigate the potential association between POI and CVD utilizing the method of Mendelian randomization (MR). MR analyses utilized summary statistics from the most extensive genome-wide association studies (GWAS) on POI and CVD extracted from European ancestry cohorts and the FinnGen biobank. The inverse variance-weighted (IVW) method was the primary MR analysis technique. Supplementary analyses were performed using MR-Robust Adjusted Profile Score (MR-RAPS). Cochran's Q statistic, MR-Egger, and weighted median MR models were employed to further assess heterogeneity and horizontal pleiotropy. Causal effects of POI on coronary heart disease (odds ratio [OR] = 1.048, 95% confidence interval [CI]: 1.006-1.091; = 0.023)] and ischemic stroke (OR = 1.010, 95% CI: 1.000-1.020; = 0.0498) were found. However, we did not observe a significant correlation between POI and hypertension (OR = 0.999, 95% CI: 0.994-1.004, p = 0.691), heart failure (OR = 1.009, 95% CI: 0.999-1.020, p = 0.0725), atrial fibrillation (OR = 0.995, 95% CI: 0.986-1.004, p = 0.3035), and myocardial infarction (OR = 1.002, 95% CI: 0.991-1.013, p = 0.7061). POI was causally associated with coronary heart disease and ischemic stroke, with no apparent impact on hypertension, heart failure, atrial fibrillation, or myocardial infarction. The causal relationship between POI and CVD underscores the imperative for proactive cardiovascular risk management in individuals with POI.
Inflammation exerts an essential role in gestational diabetes mellitus (GDM), but the relationship between peripheral blood inflammatory markers and GDM remains unclear. The purpose of this study was to explore the relat...Inflammation exerts an essential role in gestational diabetes mellitus (GDM), but the relationship between peripheral blood inflammatory markers and GDM remains unclear. The purpose of this study was to explore the relationship between inflammatory markers and GDM in US adults. Data were extracted from the National Health and Nutrition Examination Survey. Five inflammatory markers were derived from complete blood count. Survey-weighted multivariable logistic regression models were used to assess the association between inflammatory markers and GDM. Restricted cubic splines and subgroup analyses were conducted to validate the stability of the results. Finally, a total of 2363 women aged 20-44 were included based on specific criteria, with 229 self-reported GDM cases (9.69%). The increased lymphocyte-monocyte ratio (LMR) was associated with the higher risk of GDM, aOR = 1.82 (CI:1.30-2.56). Compared with the lowest tertile, the highest tertile group of LMR showed a significantly increased risk of GDM, aOR = 2.24 (CI: 1.28-2.85). Conversely, the highest tertile group of systemic inflammation response index (SIRI) was negatively associated with GDM, aOR = 0.61 (95% CI: 0.40-0.94). And high platelet-lymphocyte ratio (PLR) levels are related to a lower risk of GDM. No non-linear relationships were observed. Furthermore, subgroup analysis revealed that the association between LMR, SIRI, and GDM remained consistent with the overall results. Our study indicated that LMR, PLR, and SIRI may be potential predictors of GDM. Further large-scale prospective study is needed to investigate the role of LMR, PLR and SIRI in GDM.
OBJECTIVE: To compare the efficacy of oral and transdermal estrogens in improving the quality of life in perimenopausal and recently postmenopausal women. METHODS: 257 women aged 40-55 years, within three years after the...OBJECTIVE: To compare the efficacy of oral and transdermal estrogens in improving the quality of life in perimenopausal and recently postmenopausal women. METHODS: 257 women aged 40-55 years, within three years after their final menstrual period were randomized to receive transdermal oestrogel (t-E2) ( = 128) or oral estradiol valerate (o- E2V) ( = 129; both with micronized progesterone 200 mg for 14 days each month). Menopausal symptoms were recorded at screening and at 4, 12, and 24 weeks post-randomization. Menopausal symptoms were evaluated using the Menopause-Specific Quality of Life (MENQOL) questionnaire. RESULTS: Significant improvements of MENQOL scores were observed in both groups compared with baseline. The decrease of MENQOL scores after treatment showed almost no difference between the two groups ( > 0.05) except the VMS domain which indicated a better result in oral estrogen group after 24 weeks. CONCLUSIONS: This study showed that both transdermal and oral estrogens were highly effective in relieving the overall menopausal symptoms for recently-menopausal women, with little difference in treatment efficacy between the two routes.
Uterine fibroids (UFs) are the most common benign tumors in women of reproductive age and one of the leading causes of hysterectomy in Italy. This survey aimed to report how Italian women perceive and approach UFs, in or...Uterine fibroids (UFs) are the most common benign tumors in women of reproductive age and one of the leading causes of hysterectomy in Italy. This survey aimed to report how Italian women perceive and approach UFs, in order to raise healthcare professionals (HCPs)', institutions' and women's awareness of UFs and their treatment options. 1508 Italian women aged 30-50 years completed a web-based survey, answering a structured questionnaire focused on UF prevalence, symptomatology and impact, management and awareness. UF self-reported prevalence was 28.8%. Most UF-diagnosed women had symptom(s) before diagnosis (79.0%), and more than a half of UF-diagnosed participants were symptomatic post-diagnosis (55.8%). The most common symptoms after diagnosis were heavy menstrual bleeding (73.1%), dysmenorrhea (50.4%) and pelvic pain (36.8%). UFs negatively affected the quality of life of most symptomatic women, as well as sexuality and employment. Private gynecologists were the key reference HCPs for consultation and UF diagnosis. The most common UF treatments for symptomatic women were surgery (49.2%), followed by oral contraceptives (39.3%). Surgery was also performed for 22.9% of asymptomatic participants. UF-diagnosed participants were not involved in therapeutic choices in 37.6% of cases. Women's knowledge about UFs was mostly superficial (58.7% of all participants), with gynecologists and family/friends as main information sources. Patient-physician communication was rather unsatisfactory, especially about UF therapeutic options and disease impact on sexuality, fertility and lifestyle. This survey highlights that there is still a need to promote patient's knowledge about UFs and empowerment in treatment decision.
Objectives: Premature ovarian insufficiency (POI) is a serious condition that affects women worldwide, In recent years, the number of research publications on POI has increased over the last decades because of the advanc...Objectives: Premature ovarian insufficiency (POI) is a serious condition that affects women worldwide, In recent years, the number of research publications on POI has increased over the last decades because of the advancement of cutting-edge research in gynecology and the deepening of disciplinary interactions. At the same time, there is a more urgent need to systematically analyze and review existing studies to generalize the research paradigm and disciplinary structure of the field under technological changes. Materials and methods: We selected the top 100 most cited papers in the Web of Science (WOS) SCI-Expanded database. Knowledge graphs were constructed through the VOS viewer, Cite Space, and Scimago Graphica software, and then relevant information retrieved from the literature was edited using Excel to assess research priorities and trends in the field. Results: A total of 53 periodicals from 34 different nations and regions published the 100 most-cited publications between 1999 and 2024. The Journal of Clinical Endocrinology & Metabolism published the majority of the papers, while The Lancet had the highest average number of citations per piece. The United States of America produced the highest contribution in terms of publications, with China and France closely trailing after. In terms of total publications, Erasmus MC, Shanghai Jiao Tong University, and Shandong University each contributed the highest number of papers. The main categories were obstetrics and gynecology, endocrinology and metabolism, and reproductive biology. The top five keywords were: failure, women, ANTI-MULLERIAN HORMONE, NATURAL MENOPAUSE, and AGE. The study of HERITAGE AND GENETICS, CARDIOVASCULAR DISEASES, and CELL BIOLOGY AND IMMUNOGENETICS is becoming more and more popular in POI, as shown by cluster analysis. Conclusions: Bibliometric analysis enables POI researchers to efficiently and visibly pinpoint the cutting-edge areas and focal points of their study. Potential topics of future study may include genetic and molecular biological pathways, cardiovascular pathology, and immunology.
BACKGROUND: The effects of granulose cell (GC) senescence on premature ovarian insufficiency/premature ovarian failure have been extensively examined, the association between GC senescence and ovarian aging remains to be...BACKGROUND: The effects of granulose cell (GC) senescence on premature ovarian insufficiency/premature ovarian failure have been extensively examined, the association between GC senescence and ovarian aging remains to be clarified. METHODS: Human and mouse GCs from young/control and old/advanced maternal age (AMA) groups were collected, and GC senescence was determined. The role of the DNMT1-p53 axis in GC senescence during ovarian aging was examined and validated in a KGN cell senescence model. RESULTS: SA-beta-gal-positive GCs were significantly increased in the AMA group, accompanied by activation of the p53-p21 pathway, which was also found in GCs from aged mice and HO-induced senescent KGN cells. Pyrosequencing methylation analysis revealed that increased expression of p53 was associated with decreased average methylation levels of CpG sites (-1031, -1019, -1012 and -1008) within the promoter CpG island in senescenct GCs and KGN cells. We further found that decreased DNA-methyltransferase 1 (DNMT1) expression was responsible for the reduced methylation levels of the CpG sites. CONCLUSION: Decreased DNMT1 with hypomethylation of the CpG sites within the promoter CpG island in GCs is involved in ovarian aging.
OBJECTIVE: It has been established that male cigarette smoking has a negative effect on the semen quality and that it can induce DNA damage leading to worsening of reproductive outcomes. The aim of our large retrospectiv...OBJECTIVE: It has been established that male cigarette smoking has a negative effect on the semen quality and that it can induce DNA damage leading to worsening of reproductive outcomes. The aim of our large retrospective study is to determine the influence of male cigarette smoking on assisted reproduction, more specifically in IVF and ICSI outcomes. MATERIALS AND METHODS: Our study included all consecutive infertile couples (with a nonsmoking female partner) having their first IVF/ICSI cycle. All patients had smoking assessment. Smokers were further classified into mild (1-10 cigarettes/day), moderate (11-20 cigarettes/day) or heavy smokers (>20 cigarettes/day). The primary outcome was live birth rates (LBR). RESULTS: The overall number of patients analyzed was 4004 and among them 433 (10.8%) were smokers. Baseline characteristics, such as female age and BMI differed significantly between nonsmokers and smokers. The crude analysis showed higher positive hCG and LBR in smokers (positive hCG 28.34% in nonsmokers vs 33.95% in smokers, = 0.015; LBR 23.55% in nonsmokers vs 28.64% in smokers, = 0.019) However after adjustment for relevant confounders (female age, BMI, cause of infertility, number of oocytes retrieved, insemination procedure, number of embryos transferred and day of embryo transfer) the smoking status was not significantly associated with fresh LBR (OR = 1.16, CI = 0.92-1.48; = 0.2). The results were replicated after classification of smoking into mild/moderate/heavy [OR for nonsmokers (reference category) vs. mild vs. moderate vs. heavy= 1, 1.17, 1, 2.99; = 0.18)]. CONCLUSION: Male smoking does not seem to impair live birth rates in patients undergoing IVF/ICSI treatment.
BACKGROUND: Gestational diabetes mellitus (GDM) is globally recognized as a significant pregnancy-related condition, contributing to complex complications for both mothers and infants. Traditional glucose tolerance tests...BACKGROUND: Gestational diabetes mellitus (GDM) is globally recognized as a significant pregnancy-related condition, contributing to complex complications for both mothers and infants. Traditional glucose tolerance tests lack the ability to identify the risk of GDM in early pregnancy, hindering effective prevention and timely intervention during the initial stages. OBJECTIVE: The primary objective of this study is to pinpoint potential risk factors for GDM and develop an early GDM risk prediction model using neural networks to facilitate GDM screening in early pregnancy. METHODS: Initially, we employed statistical tests and models, including univariate and multivariate logistic regression, to identify 14 potential risk factors. Subsequently, we applied various resampling techniques alongside a multi-layer perceptron (MLP). Finally, we evaluated and compared the classification performances of the constructed models using various metric indicators. RESULTS: As a result, we identified several factors in early pregnancy significantly associated with GDM ( < 0.05), including BMI, age of menarche, age, higher education, folic acid supplementation, family history of diabetes mellitus, HGB, WBC, PLT, Scr, HBsAg, ALT, ALB, and TBIL. Employing the multivariate logistic model as the baseline achieved an accuracy and AUC of 0.777. In comparison, the MLP-based model using NearMiss exhibited strong predictive performance, achieving scores of 0.943 in AUC and 0.884 in accuracy. CONCLUSIONS: In this study, we proposed an innovative interpretable early GDM risk prediction model based on MLP. This model is designed to offer assistance in estimating the risk of GDM in early pregnancy, enabling proactive prevention and timely intervention.
OBJECTIVES: This study aims to investigate the effects and potential mechanisms of berberine in conjunction with Jianpi Yishen Huazhuo formulation (JPYSHZF) on obese rats that serve as a model for polycystic ovary syndro...OBJECTIVES: This study aims to investigate the effects and potential mechanisms of berberine in conjunction with Jianpi Yishen Huazhuo formulation (JPYSHZF) on obese rats that serve as a model for polycystic ovary syndrome (PCOS). METHODS: Letrozole combined with high-fat diet (HFD) was used to establish an overweight PCOS rat model. After successful modeling, each intervention group was monitored for 28 d. An oral glucose tolerance test (OGTT) is performed to assess glucose metabolism. Enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of sex hormones and serum levels of gastrointestinal hormones in rats. Biochemical analyzers were used to assess blood lipid levels. The protein expression levels of p38, PI3K, GLUT4, and AKT in ovarian tissue were demonstrated using Western Blotting (WB). Real-time fluorescence quantitative PCR (RT-qPCR) was used to measure the mRNA expression levels of p38, PI3K, GLUT4 and AKT in the same tissue. The morphological changes of ovarian tissue were observed using Hematoxylin-eosin (HE). RESULTS: Treatment with berberine in conjunction with JPYSHZF has been shown to reduce serum testosterone T and luteinizing hormone (LH) levels while increasing serum follicle-stimulating hormone (FSH) and E2 levels. This combination therapy also decreases the LH/FSH ratio and ameliorates polycystic ovary-like pathological changes in the ovaries of rats with PCOS. Additionally, this treatment decreases serum TC, TG, and LDL-c levels while increasing HDL-c levels. It also reduces levels of GLU and Ghrelin while enhancing levels of CCK, PYY, and GLP-1. Furthermore, the relative 6 of PI3K and AKT proteins, as well as the mRNA levels of PI3K, GLUT4, and AKT, were found to be increased. CONCLUSIONS: Berberine combined with JPYSHZF can improve the sex hormone levels, ovarian function, glucose and lipid metabolism levels, and gastrointestinal hormone levels in obese PCOS rats by activating the PI3K/AKT signaling pathway, thereby playing a role in treating obese PCOS.
PURPOSE: This study aimed to explore the characteristics of intestinal microflora polymorphism in postmenopausal women, and to determine the pathophysiological changes of gene polymorphism of intestinal flora and bone me...PURPOSE: This study aimed to explore the characteristics of intestinal microflora polymorphism in postmenopausal women, and to determine the pathophysiological changes of gene polymorphism of intestinal flora and bone metabolism in postmenopausal osteoporosis (PMOP) patients. METHODS: A total of 104 postmenopausal women with PMOP or normal bone density were included. Lifestyle, hip T-score, bone metabolism indexes (25(OH)D, PTH, β-CTX, PINP), intestinal mucous membrane barrier function (diamine oxidase, D-lactic acid, LPS), gene polymorphisms, and characteristics of gut microbiota were examined. RESULTS: Women with PMOP had reduced physical activity, less dietary protein and calcium intake, lower levels of 25(OH)D, hip T-score, and BMD, but PMOP group had increased total energy and fat intake, and higher levels of PTH, β-CTX, diamine oxidase, D-lactic acid, and LPS ( < .05 for all), as compared with normal subjects. Analyses of the α- and β-diversity of fecal microbiota indicated remarkably differences in postmenopausal women with or without PMOP. In details, individuals with PMOP had increased abundances of some genera (e.g. and ), but decreased abundances of some genera (e.g. and ). Furthermore, use of a random forest model based on differential abundant taxa and ROC analysis could efficiently identify women with PMOP in the present cohort (AUC = 0.93). CONCLUSION: The incidence of PMOP was closely associated with fecal microbial compositions and intestinal functional changes. The present findings supported potential applications of gut microbiome analysis for early diagnosis of PMOP, and provided potential therapeutic targets.
PURPOSE: To comprehensively compare and rank hormone therapy for patients with perimenopausal syndrome. METHODS: A comprehensive search was conducted on PubMed, Embase, Cochrane Library, Web of Science, CNKI, VIP, and Wa...PURPOSE: To comprehensively compare and rank hormone therapy for patients with perimenopausal syndrome. METHODS: A comprehensive search was conducted on PubMed, Embase, Cochrane Library, Web of Science, CNKI, VIP, and Wanfang databases from inception to August 20, 2024. The quality of the included randomized controlled trials (RCTs) were measured by the Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) method was applied to grade the quality of evidence in this network meta-analysis. Network plots were depicted to show direct and indirect comparisons of hormone therapy for each outcome. The influences of different hormone therapy on the outcomes were illustrated forest plots and league tables. Rank probabilities showed the ranking of different administration routes. RESULTS: Seven studies involving 704 perimenopausal syndrome patients were included. The rank probabilities suggested that oral estradiol (E combined with medroxyprogesterone and general health guidance had the highest likelihood to be the optimal therapy for the severity of menopausal syndrome. General health guidance combined with oral E was less likely to have a nausea and vomiting, and breast pain. CONCLUSION: Oral E and medroxyprogesterone or general health guidance combined with oral E may be the effective and safe option for the management of perimenopausal syndrome.
INTRODUCTION: The clinical study aimed to evaluate the levels of serum kisspeptin, NKB, and GABA in Chinese patients with polycystic ovary syndrome (PCOS) and explore their association with hormonal profiles, as well as...INTRODUCTION: The clinical study aimed to evaluate the levels of serum kisspeptin, NKB, and GABA in Chinese patients with polycystic ovary syndrome (PCOS) and explore their association with hormonal profiles, as well as the relationship between these levels in PCOS patients and controls. METHODS: From December 2022 to December 2023, medical records of 60 individuals diagnosed with PCOS and 32 healthy subjects were obtained. Serum kisspeptin, NKB and GABA levels were quantified using enzyme-linked immunosorbent assay (ELISA) kits. To assess the correlation, either Pearson's or Spearman's analytical method was employed between serum kisspeptin, NKB, and GABA levels and hormonal profiles. RESULTS: The results showed that serum kisspeptin and NKB levels were significantly lower in PCOS patients (﹤.05), while GABA levels were elevated compared to those in the control group (﹤.05). In PCOS patients, kisspeptin was notably positive-correlated with LH and LH/FSH (﹤.05), but no significant correlation was found between NKB, GABA, and hormonal profiles. In PCOS, GABA levels had a strong positive correlation with NKB levels ( = 0.613, = .000), but this was not observed in the control group. In control patients, kisspeptin levels were positively associated with NKB ( = 0.475, = .011), strongly negatively correlated with GABA levels ( = -0.773, = .000), but these were not observed in the PCOS group. CONCLUSION: The study concluded that patients with PCOS have dysregulated levels of serum kisspeptin, NKB, and GABA and that they may have paradoxical effects under physiological and pathological situations.
BACKGROUND: Polycystic ovary syndrome (PCOS) is an endocrine disorders and characterized by polycystic ovary morphology and oligomenorrhea, affecting fertility and health condition of female around the world. The causati...BACKGROUND: Polycystic ovary syndrome (PCOS) is an endocrine disorders and characterized by polycystic ovary morphology and oligomenorrhea, affecting fertility and health condition of female around the world. The causative factors of PCOS are complex, and genetic structure remains a long-standing medical challenge in genetics. Previous genome-wide association study (GWAS) showed that Wing-less-related integration site (Wnt) signaling is the most affected pathway among PCOS-related risk genes, and genetic mutations in the Wnt/β-catenin signaling may lead to abnormal development of PCOS. OBJECTIVE: To explore the possibility of axis inhibitor-2 () variants in Chinese women with PCOS and assess their pathogenicities. METHODS: A total of 365 Chinese women with PCOS and 905 women without PCOS as control were recruited from Jiangxi Provincial Maternal and Child Health Hospital, All of the 11 exons and flanking regions of the gene were amplified by polymerase chain reaction (PCR), the potential variants were analyzed by Sanger sequencing. The evolutionary conservation analysis of the identified Axin-2 mutant was analyzed among 15 vertebrates from to . The protein structure change was analyzed between the wild-type and mutation-type. The pathogenicity of variant was further analyzed in silico. RESULTS: We totally identified 7 genetic variants of in this study, including 4 synonymous and 3 missense. Among them, we find a rare deleterious missense variant [p.R714W (c.2140C > T)]. The allele frequencies of this variant were 0.82% and 0.17% in PCOS cases and matched controls, respectively. And it was ranging from 7.89e-5 to 1.47e-4 in public databases. Fisher's exact test indicated that the allele frequencies in PCOS were 0.05 compared to both the controls and the databases. Especially, the mutant amino acid site is highly conserved in vertebrates, while the mutation changed the 714th arginine to tryptophan resulting in significant change in the protein structural of Axin-2. CONCLUSION: In this study, we identified a rare deleterious missense mutation [p.R714W (c.2140C > T)] in Chinese women with PCOS, and this mutant is probably pathogenic. This study may provide a new perspective on revealing the genetic variation of PCOS.
BACKGROUND: Thyroid autoimmune disorders (ADs) are common in midlife women and can impact various aspects of health, including sexual function. The effect of thyroid autoimmunity on the clinical manifestations of vulvova...BACKGROUND: Thyroid autoimmune disorders (ADs) are common in midlife women and can impact various aspects of health, including sexual function. The effect of thyroid autoimmunity on the clinical manifestations of vulvovaginal atrophy (VVA) remains unclear. OBJECTIVE: To explore the relationship between thyroid ADs and VVA signs and symptoms in a sample of postmenopausal women. METHODS: Cross-sectional study including postmenopausal women not using systemic hormone therapy. VVA signs were assessed using the vaginal health index (VHI) and vulvar health index (VuHI); VVA symptoms were rated on a four-point severity scale. RESULTS: Among 112 women enrolled, 28 had thyroid ADs. A significantly higher percentage of women with thyroid ADs showed vaginal atrophy (75 vs. 45.2%, < .05). A greater proportion of women with thyroid ADs exhibited vulvar atrophy or both vaginal and vulvar atrophy, though these differences were not statistically significant. Women with thyroid ADs reported significantly higher scores for dryness, burning/itching, irritation/inflammation, and dyspareunia compared to those without it. A higher percentage of women with thyroid ADs experienced severe dyspareunia (45 vs. 20.6%, < .05), severe burning/itching (33.3 vs. 9.1%, < .05), and severe stress urinary incontinence (17.9 vs. 3.6%, < 0.05). CONCLUSIONS: This study suggests that thyroid ADs may contribute to genital aging, with an apparent greater involvement in vaginal signs of atrophy. Women with thyroid ADs reported more severe VVA symptoms, but specific symptomatological clusters should be investigated in larger samples. Our data support the need to explore further the role of thyroid disorders in VVA.
BACKGROUND: A prolonged release combined oral contraceptive (COC) pill, containing 2 mg dienogest (DNG)/0.02 mg ethinylestradiol (EE) in a 24 + 4 daily dosing regimen has recently been approved in Europe. OBJECTIVE: To d...BACKGROUND: A prolonged release combined oral contraceptive (COC) pill, containing 2 mg dienogest (DNG)/0.02 mg ethinylestradiol (EE) in a 24 + 4 daily dosing regimen has recently been approved in Europe. OBJECTIVE: To determine if this COC impacts coagulation and fibrinolytic factors in comparison to an immediate release COC containing 3 mg drospirenone (DRSP)/0.02 mg EE. METHOD: Forty-four patients received the novel product, and forty-seven the comparator (immediate release formulation) during nine complete cycles. Coagulation and fibrinolytic parameters were evaluated: activated protein C resistance ratio, Antithrombin III (AT III), C-reactive protein, Factor VII, Factor VIII, and D-Dimer. RESULTS: Compared to baseline, at the end of the study both groups displayed significantly higher mean values for AT III: 1.06 mg/mL (standard deviation [SD], 95% CI, 0.98-1.15) for the DNG/EE formulation and 1.04 mg/mL (SD 95% CI, 0.96-1.12) for the comparator ( 0.0006 and 0.0009, respectively). D-dimer showed a non-significant slight reduction in the DNG/EE group, from 276.62 ng/mL (SD, 95% CI, 228.92-334.26) before treatment to 243.98 ng/mL (SD, 95% CI, 192.45-309.31) ng/mL after treatment. Contrarily, the comparator displayed a non-significant rise in D-dimer values from 246.46 ng/mL (SD, 95% CI, 205.44-295.66) ng/mL to 275.30 ng/mL (SD, 95% CI 219.21-345.75; 0.4520). All other parameters showed no significant differences before and after the treatment for both groups. CONCLUSION: The COC 2 mg DNG/0.02 mg EE was not associated with any meaningful changes in the analyzed coagulation and fibrinolytic parameters indicating that a prolonged release formulation does not impact on these factors. CLINICAL TRIAL REGISTRY: EudraCT: 2019-0018-77-97.
OBJECTIVE: To investigate the effects of light fasting diet therapy, including flaxseed powder supplementation, on lipid metabolism and sex hormone levels in patients with polycystic ovary syndrome (PCOS) combined with i...OBJECTIVE: To investigate the effects of light fasting diet therapy, including flaxseed powder supplementation, on lipid metabolism and sex hormone levels in patients with polycystic ovary syndrome (PCOS) combined with infertility. METHODS: A total of 104 PCOS patients with combined infertility were divided into the control group ( = 52) and intervention group ( = 52) using a random number table method. Over a two-month study period, the control group received light fasting diet therapy with rice flour as a placebo, while the intervention group received light fasting diet therapy supplemented with flaxseed powder. Differences in general clinical data, anthropometric indicators, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), fasting plasma glucose (FPG), fasting insulin (FINS), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C)) were compared between the two groups. RESULTS: After treatment, both groups showed significant reductions in FSH, LH, E2, and P levels compared to baseline ( < .05). In the intervention group, the mean FINS and HOMA-IR levels were significantly lower than those in the control group following 2 months of treatment ( < .05). Furthermore, TC, TG, and LDL-C levels were significantly reduced in the intervention group compared to the control group ( < .05). CONCLUSION: Light fasting diet therapy, especially with flaxseed powder, improves obesity, lipid, and glucose metabolism disorders in PCOS patients with infertility. However, longitudinal studies are needed to better understand these associations and assess long-term effects before considering this intervention as a standard clinical recommendation for PCOS.