Menstrual Cycle Parameters Research Articles

MANEJO NUTRICIONAL DA RESISTÊNCIA À INSULINA NA SÍNDROME DE OVÁRIO POLICÍSTICO

Introduction: Polycystic Ovary Syndrome (PCOS) is the most common hormonal disorder among women during the ovulation and menstrual periods. Its origin is still unknown; however, the treatment of the disease involves changes in dietary habits and physical activity practices. Reducing carbohydrate intake has positive effects on PCOS, as this low carbohydrate consumption allows for depletion of muscle and hepatic glycogen stores. Objective: To evaluate the nutritional management of insulin resistance in PCOS. Materials and Methods: Literature reviews were conducted focusing on the last cinco years, using the PubMed, Scielo, and Virtual Health Library (BVS) databases. Result: A hypocaloric diet showed improvements in metabolic rates, menstrual cycle, weight loss, and insulin resistance parameters. Conclusion: Although there is no specific diet for women with insulin resistance and polycystic ovary syndrome, the results of studies have shown that low-calorie diets in conjunction with physical activity can influence the reduction of anthropometric measurements of patients, and therefore assist in the treatment of PCOS and insulin resistance.

تأثير لقاح كوفيد -19 على الدورة الشهرية

Background: The implementation of vaccines is a major step in saving humanity from the consequences of COVID-19, and there has become hope for everyone in the world. Menstruation is a key indicator of overall women's health. The COVID-19 vaccination has been associated with changes in the menstrual cycle. Objective: To evaluate the effects of COVID-19 vaccines on the menstrual cycle. Methods: This is a face-to-face interview-based cross-sectional study that recruited 403 vaccinated women with the COVID-19 vaccine who had normal MC before receiving the vaccine for at least six months in Mosul, Iraq, from February 1 to July 31, 2022. We asked the women about their menstrual cycle parameters before and after the vaccination. The results were analyzed statistically. Results: The most frequent age group among study participants was 20–34 years (52.9%). About half of women (58.3%) had received the Pfizer vaccine. 12.2% and 13.65% of women reported significant changes in their menstrual cycle following the first and second doses, respectively. These changes included irregularities in the cycle and modifications in the amount and duration of menses, and the Pfizer vaccine was significantly responsible for these changes. Conclusions: In a small number of women who had a normal menstrual cycle before vaccination, post-Covid-19 vaccination menstrual cycle changes occurred, and the reported changes were not critical. This result can reassure the community about the vaccine's impact on the menstrual cycle.

Phthalate metabolites in urine and follicular fluid in relation to menstrual cycle characteristics in women seeking fertility assistance

BackgroundPhthalates have been shown to disrupt the estrous cycle in animal studies. However, epidemiological research investigating their associations with menstrual cycle characteristics is limited. ObjectiveTo explore the relationships between phthalate exposure and menstrual cycle characteristics among women seeking fertility assistance. MethodsWe determined the levels of eight phthalate metabolites in both follicular fluid (FF) and urine specimens collected from 441 women in the Tongji Reproductive and Environmental (TREE) cohort, using high-performance liquid chromatography and tandem mass spectrometry. Information about menstrual cycle parameters was obtained through a questionnaire. The impacts of individual and joint exposure to phthalates on menstrual cycle characteristics were assessed using multivariable linear regression, Poisson regression, and quantile g-computation approaches. ResultsAfter adjusting for relevant covariates, we found that per log10-unit increase in mono(2-ethylhexyl) phthalate (MEHP) level in urine specimens was associated with a decrease of 0.20 days (95 % CI: −0.37, −0.03) in bleeding duration. We also observed that mono(2-ethyl-5-carboxypentyl) phthalate (MECPP) and the sum of di(2-ethylhexyl) phthalate (DEHP) metabolites (∑DEHP) concentrations in FF samples were inversely related to cycle length [β = −1.92 (95 % CI: −3.10, −0.75) and −1.87 (95 % CI: −3.56, −0.19), respectively]. However, we generally observed null associations between phthalate metabolites and irregular cycle, dysmenorrhea, hypomenorrhea, or cycle length variation. Furthermore, we also found that phthalate metabolite mixtures in FF and urine were generally unrelated to menstrual cycle characteristics. ConclusionOur findings suggest that some DEHP metabolites in FF and urine are inversely associated with menstrual cycle length and menstrual bleeding duration in women attending a fertility center.

A retrospective case-control study on menstrual cycle changes following COVID-19 vaccination and disease

There has been increasing public concern that COVID-19 vaccination causes menstrual disturbance regarding the relative effect of vaccination compared to SARS-CoV-2 infection. Our objectives were to test potential risk factors for reporting menstrual cycle changes following COVID-19 vaccination and to compare menstrual parameters following COVID-19 vaccination and COVID-19 disease. We performed a secondary analysis of a retrospective online survey conducted in the UK in March 2021. In pre-menopausal vaccinated participants (n= 4,989), 18% reported menstrual cycle changes after their first COVID-19 vaccine injection. The prevalence of reporting any menstrual changes was higher for women who smoke, have a history of COVID-19 disease, or are not using estradiol-containing contraceptives. In a second sample including both vaccinated and unvaccinated participants (n= 12,579), COVID-19 vaccination alone was not associated with abnormal menstrual cycle parameters, while a history of COVID-19 disease was associated with an increased risk of reporting heavier bleeding, "missed" periods, and inter-menstrual bleeding.

P-691 Assessment of ovarian vascularity by three-dimensional vaginal power Doppler on day seven of menstrual cycle to predict the number of eggs collected in antagonist cycle

Abstract Study question Could ovarian vascularity indices on day 2 and 7 of stimulation, measured by 3-dimensional (3D) vaginal power Doppler, predict after controlled ovarian stimulation? Summary answer Ovarian vascularity index (VI) on day 7 may be an indicator of poor (<three mature eggs collected) ovarian responses to gonadotropins. What is known already Poor and/or hyper ovarian responses to gonadotropins may be related to cycle cancellation during controlled ovarian stimulation (COS). In this context, gonadotropin dose is often individualized using patient features that predict ovarian response (such as age, antral follicular count (AFC) and anti-Müllerian hormone (AMH)). In parallel, ovarian vascularity color doppler is a valuable evaluation method to predict the ovarian hyperstimulation syndrome and the growth/maturity of Graafian follicles. The aim of the present study is to estimate the utility of 3-dimensional vaginal power Doppler and ovarian vascular flow indices in the prediction of the number of mature occytes collected after COS. Study design, size, duration A prospective study was conducted on 296 couples undergoing intracytoplasmic sperm injection cycle at Al Hadi Laboratory and Medical center, Beirut, Lebanon. It was performed between January 2020 and dec 2021. Couples were categorized into poor responders group (3 or less metaphase II (MII) eggs collected) (36.1%), high responders group (16 or more MII eggs collected) group ( 6.7%), and normal responders group (more than 3 and less than 16 MII eggs collected) (57,2%). Participants/materials, setting, methods On the second and seventh day of the menstrual cycle, ovarian volume and vascularity parameters (vascularity index (VI), flow index (FI), and vascularity flow index (VFI)) were measured using the 3D power Doppler and the Virtual Organ Computer-Aided Analysis. On day 2 , the antral follicle count was evaluated and a blood sample for AMH testing was collected. Women included in the study have undergone COS using GnRH antagonist protocol. Main results and the role of chance Mean age was 35,88+/- 6 year , day2 VI and day2 VFI correlates with the number of egg collected (p = 0.014 and 0.045 respectively). 9 parameters were used to predict poor and high ovarian responses (Age, AMH, AFC, day2 VI, day2 FI , day2 VFI , day7 VI, day7 FI and day7 VFI) in a Receiver operator characteristics (ROC) curve model . Ovarian day7 FI significantly predicted poor ovarian response to gonadotropins (p = 0.038) with an area under the curve of 0.679. AFC predicted also poor ovarian response to gonadotropins (p = 0.006) . In parallel, AFC significantly predicted high ovarian response to gonadotropins (p = 0.002) and AUC (0.778) while all other 3D doppler parameters couldn’t predict high responders. Limitations, reasons for caution It will be necessary to perform a prospective analysis on a broad sample size to validate these findings. In addition, it will be interesting to assess the impact of ovarian vascularity on pregnancy outcomes. Wider implications of the findings Assessing ovarian vascularity during ovarian stimulation can help reduce the rate of cycle cancellation. In addition, more studies are welcomed in the field to unravel the mechanisms behind altered ovarian vascularity and to test the possibility of restoring normal ovarian physiology. Trial registration number Not Applicable

Menstrual Cycle Parameters Are Not Significantly Different After COVID-19 Vaccination.

Background: Some studies have suggested minor changes in the menstrual cycle after COVID-19 vaccination, but more detailed analyses of the menstrual cycle are needed to evaluate more specific changes in the menstrual cycle that are not affected by survey-based recall bias. Materials and Methods: Using a pretest-post-test quasi-experimental evaluation of menstrual cycle parameters before and after COVID-19 vaccination, we conducted an anonymous online survey of two groups of North American women who prospectively monitor their menstrual cycle parameters daily including bleeding patterns, urinary hormone levels using the ClearBlue Fertility Monitor, or cervical mucus observations. The primary outcome measures were cycle length, length of menses, menstrual volume, estimated day of ovulation (EDO), luteal phase length, and signs of ovulation. Perceived (subjective) menstrual cycle changes and stressors were also evaluated in this study as secondary outcome measures. Results: Of the 279 women who initiated the survey, 76 met the inclusion criteria and provided 588 cycles for analysis (227 pre-vaccine cycles, 145 vaccine cycles, 216 post-vaccine cycles). Although 22% of women subjectively identified changes in their menstrual cycle, there were no significant differences in menstrual cycle parameters (cycle length, length of menses, EOD, and luteal phase length) between the pre-vaccine, vaccine, and post-vaccine cycles. Conclusions: COVID-19 vaccines were not associated with significant changes in menstrual cycle parameters. Perceived changes by an individual woman must be compared with statistical changes to avoid confirmation bias.

Temporal variability in quantitative human gut microbiome profiles and implications for clinical research

While clinical gut microbiota research is ever-expanding, extending reference knowledge of healthy between- and within-subject gut microbiota variation and its drivers remains essential; in particular, temporal variability is under-explored, and a comparison with cross-sectional variation is missing. Here, we perform daily quantitative microbiome profiling on 713 fecal samples from 20 Belgian women over six weeks, combined with extensive anthropometric measurements, blood panels, dietary data, and stool characteristics. We show substantial temporal variation for most major gut genera; we find that for 78% of microbial genera, day-to-day absolute abundance variation is substantially larger within than between individuals, with up to 100-fold shifts over the study period. Diversity, and especially evenness indicators also fluctuate substantially. Relative abundance profiles show similar but less pronounced temporal variation. Stool moisture, and to a lesser extent diet, are the only significant host covariates of temporal microbiota variation, while menstrual cycle parameters did not show significant effects. We find that the dysbiotic Bact2 enterotype shows increased between- and within-subject compositional variability. Our results suggest that to increase diagnostic as well as target discovery power, studies could adopt a repeated measurement design and/or focus analysis on community-wide microbiome descriptors and indices.

P–688 Assessment of ovarian vascularity by three-dimensional vaginal power Doppler on day two of menstrual cycle to predict the number of mature eggs collected

Abstract Study question Could ovarian vascularity indices, measured by 3-dimensional (3D) vaginal power Doppler, predict the number of mature oocytes collected after controlled ovarian stimulation? Summary answer Ovarian vascularity index (VI) may be an indicator of poor (<three mature eggs collected) and high (>ten mature eggs collected) ovarian responses to gonadotropins. What is known already Poor and/or hyper ovarian responses to gonadotropins may be related to cycle cancellation during controlled ovarian stimulation (COS). In this context, gonadotropin dose is often individualized using patient features that predict ovarian response (such as age, antral follicular count (AFC) and anti-Müllerian hormone (AMH)). In parallel, ovarian vascularity color doppler is a valuable evaluation method to predict the ovarian hyperstimulation syndrome and the growth/maturity of Graafian follicles. The aim of the present study is to estimate the utility of 3-dimensional vaginal power Doppler and ovarian vascular flow indices in the prediction of the number of mature occytes collected after COS. Study design, size, duration A prospective study was conducted on 200 couples undergoing intracytoplasmic sperm injection cycle at Al Hadi Laboratory and Medical center, Beirut, Lebanon. It was performed between January 2020 and July 2020. Couples were categorized into poor responders group (3 or less metaphase II (MII) eggs collected) (n = 43), high responders group (10 or more MII eggs collected) group (n = 66), and normal responders group (more than 3 and less than 10 MII eggs collected) (n = 66). Participants/materials, setting, methods On the second day of the menstrual cycle, ovarian volume and vascularity parameters (vascularity index (VI), flow index (FI), and vascularity flow index (VFI)) were measured using the 3D power Doppler and the Virtual Organ Computer-Aided Analysis. On the same day, the antral follicle count was evaluated and a blood sample for AMH testing was collected. Women included in the study have undergone COS using GnRH antagonist protocol. Main results and the role of chance Receiver operator characteristics (ROC) curve model was used to predict the number of mature eggs collected. 7 parameters were used to predict poor and high ovarian responses (Age, AMH, AFC, ovarian volume, VI, FI and VFI). Ovarian VI significantly predicted poor ovarian response to gonadotropins (p = 0.033 and area under the curve (AUC)=0.668). Subsequently, the cut off value was 0.0025 with 84% sensitivity and 83.3% specificity. In parallel, ovarian VI significantly predicted high ovarian response to gonadotropins (p = 0.036 and AUC (0.778)) with a cut off value 0.0375 and with 77.8% sensitivity and 78.3% specificity. Furthermore, VFI significantly predicted high ovarian response to gonadotropins (p = 0.045; AUC=0.677). Limitations, reasons for caution It will be necessary to perform a prospective analysis on a broad sample size to validate these findings. In addition, it will be interesting to assess the impact of ovarian vascularity on pregnancy outcomes. Wider implications of the findings: Assessing ovarian vascularity prior to ovarian stimulation can help reduce the rate of cycle cancellation. In addition, more studies are welcomed in the field to unravel the mechanisms behind altered ovarian vascularity and to test the possibility of restoring normal ovarian physiology. Trial registration number Not applicable

Triangle of COVID, anxiety and menstrual cycle

This study aimed to examine whether the menstrual cycles of women with regular cycles have been affected by the COVID 19 pandemic. This cross-sectional online survey study evaluated the menstrual cycle characteristics of women in the reproductive phase of their lives during the COVID-19 pandemic in May 2020. Changes before and after COVID-19 were evaluated with a paired sample t-test and chi-square test. A Pearson correlation test was used to show the relationships between variables. The study was completed with 263 participants in total. The average age of the participants was 26.3 ± 6.9 (18–45). Participants’ duration of period (p = .003) and pads used per day (p = .002) decreased compared to their experience before the COVID-19 outbreak. The mean total MSQ score was 3.1 ± 0.8 (0–4), mean STAI-1 score was 45.1 ± 9 (20–78) and mean STAI-II score was 43.3 ± 5.9 (30–69). It was found that STAI-I and STAI-II scores showed a positive correlation with MSQ-Somatic subgroup scores(r = 0.153, p = .013; 0.190, p = .002) and MSQ-Total scores (0.144, p = .020; 0.175, p = .004). With the COVID-19 pandemic, increased anxiety scores increased women's menstrual symptoms while the length of periods and the number of pads used decreased. Impact statement What is already known on this subject? The COVID 19 pandemic, has caused enormous psychological distress potentially resulting in the development of posttraumatic stress disorder. The menstrual cycle is a process that can be affected by psychological stress. What do the results of this study add? This is the first study to examine the relationship between stress caused by the COVID-19 pandemic and the menstrual cycle. The increases in the degree of anxiety and stress as a result of the COVID-19 outbreak was found to be high enough to affect the characteristics of the menstrual cycle in the women surveyed. What are the implications of these findings for clinical practice and/or further research? In a prospective study intended to be carried out after the outbreak ends in the future, it will be possible to evaluate whether the menstrual cycle parameters return to their former order and consequently this hypothesis will be able to be more definitively confirmed.

The intra-individual stability of GH biomarkers IGF-I and P-III-NP in relation to GHRH administration, menstrual cycle, and hematological parameters.

The intra-individual stability of growth hormone (GH) biomarkers IGF-I, P-III-NP, calculated GH-2000 score in relation to growth hormone-releasing hormone (GHRH) (Somatorelin) administration, menstrual cycle, and hematological parameters were investigated in four men and eight women, respectively. Moreover, the hematological parameters hemoglobin (Hb) and percentage of reticulocyte (RET%) were statistically analyzed in relation to the GH biomarker parameters for the GHRH administration study and the menstrual cycle study. Longitudinal monitoring of IGF-I and/or GH-2000 score proved to be a viable approach to detect the GHRH intake in men, as all four participants show values above individually calculated thresholds (calculated as mean ± 3SD from three baseline samples). The intra-individual variation for IGF-I, P-III-NP, and calculated GH-2000 score in women, over two consecutive menstrual cycles, was investigated and established to be higher (coefficients variations [CVs] between 12% and 186%) than in men (CVs between 3% and 12%). The GHRH administration did not influence the hematological parameters. A strong positive correlation between Hb and IGF-I (Rs = 0.73, p < 0.0001) and a borderline weak correlation between RET% and IGF-I (Rs = 0.28, p = 0.054) were noticed in the women. No correlation for the P-III-NP and the hematological parameters was seen for the females in the menstrual cycle study. The results fortify previous studies that longitudinal monitoring of IGF-I and/or GH-2000 score may be a promising method to detect doping with GH and GH stimulating agents in men, whereas the large intra-individual variation noted in women indicates that longitudinal monitoring of these biomarker may be harder to evaluate in women.

Development of a computer program for the diagnosis of polycystic ovary syndrome in women of early reproductive age

Aim. To develop the software for the diagnosis of polycystic ovary syndrome in women of early reproductive age. Material and Methods. We consecutively recruited 200 women of early reproductive age (18-35 years) with or without polycystic ovary syndrome (100 women per group) and performed standard clinical, laboratory, and ultrasound examination. In particular, we evaluated the duration of the menstrual cycle (oligo/ amenorrhea), ovarian reserve, and ultrasound parameters of the uterus and appendages (antiMullerian hormone level, ovarian volume, and antral follicle count). Anti-Mullerian hormone level was measured by means of enzyme-linked immunosorbent assay while ovarian volume and antral follicle count were examined on the 3rd day of the menstrual cycle using a transvaginal ultrasound examination. Results . We found statistically significant differences in the indicators of ovarian reserve in women of early reproductive age between the patients with and without polycystic ovary syndrome. Employing a logistic regression analysis, we developed a software for the automated diagnosis of polycystic ovary syndrome. Sensitivity and specificity of this software were 70.9% and 75.7%, respectively. The «Clinical, Laboratory, and Ultrasound Diagnostics of Polycystic Ovary Syndrome (CLOUDPOS)» software was developed and registered by Federal Intellectual Property Service (certificate No. 2019662249, date of registration 09/19/2019). Conclusion. Our software can be recommended as an accessory tool for the diagnosis of polycystic ovary syndrome.

Menstrual bleeding, cycle length, and follicular and luteal phase lengths in women without known subfertility: A pooled analysis of three cohorts.

There is variability between women for days of menstrual bleeding, cycle lengths, follicular phase lengths, and luteal phase lengths, related to age and parity. To describe total cycle length; anovulatory cycles; follicular and luteal phase lengths; and days and intensity of menstrual and non-menstrual bleeding in women without known subfertility over the course of 1year. 581 women (3,324 cycles) with no known subfertility (18-40years of age) were followed for up to 1year. Women recorded vaginal bleeding and mucus discharge daily. We used the peak day of cervical mucus as the estimated day of ovulation and the last day of the follicular phase. We used generalised linear mixed models stratified by age and parity to describe menstrual cycle parameters. The majority of women were <30years of age (74.5%), non-Hispanic White (88.6%), and nulliparous (70.4%). The mean menses length was 6.2 (1.5) days, median 6; cycle length 30.3 (6.7) days, median 29; follicular phase length 18.5 (6.5) days, median 17; and luteal phase length 11.7 (2.8) days, median 12. Nulliparous women aged ≥30years vs nulliparous women aged <30 had shorter cycles (29.2days, 95% confidence interval (CI) 27.8, 30.7 vs 31.5days, 95% CI 30.8, 32.2) and shorter follicular phases (17.6days, 95% CI 16.2, 18.9 vs 19.6days, 95% CI 18.9, 20.2). Among all women, within-woman differences between the longest and shortest menses length >3days, total cycle length >7days, follicular phase >7days, and luteal phase >3days were found in 11.6%, 43.0%, 41.7%, and 58.8% of women, respectively. Our findings confirm variability between women of menstrual cycle parameters related to age and parity, and also highlight within-woman variability in the follicular and luteal phases.

Real-world menstrual cycle characteristics of more than 600,000 menstrual cycles

The use of apps that record detailed menstrual cycle data presents a new opportunity to study the menstrual cycle. The aim of this study is to describe menstrual cycle characteristics observed from a large database of cycles collected through an app and investigate associations of menstrual cycle characteristics with cycle length, age and body mass index (BMI). Menstrual cycle parameters, including menstruation, basal body temperature (BBT) and luteinising hormone (LH) tests as well as age and BMI were collected anonymously from real-world users of the Natural Cycles app. We analysed 612,613 ovulatory cycles with a mean length of 29.3 days from 124,648 users. The mean follicular phase length was 16.9 days (95% CI: 10–30) and mean luteal phase length was 12.4 days (95% CI: 7–17). Mean cycle length decreased by 0.18 days (95% CI: 0.17–0.18, R2 = 0.99) and mean follicular phase length decreased by 0.19 days (95% CI: 0.19–0.20, R2 = 0.99) per year of age from 25 to 45 years. Mean variation of cycle length per woman was 0.4 days or 14% higher in women with a BMI of over 35 relative to women with a BMI of 18.5–25. This analysis details variations in menstrual cycle characteristics that are not widely known yet have significant implications for health and well-being. Clinically, women who wish to plan a pregnancy need to have intercourse on their fertile days. In order to identify the fertile period it is important to track physiological parameters such as basal body temperature and not just cycle length.

Comparison of metformin plus myoinositol vs metformin alone in PCOS women undergoing ovulation induction cycles: randomized controlled trial

The present study was planned to evaluate the benefit of synergetic effect of Metformin plus Myo-inositol versus Metformin alone in infertile polycystic ovarian syndrome (PCOS) women undergoing ovulation induction. One hundred and twenty infertile PCOS women were randomized: Group I (n = 60) received Metformin (500 mg) plus Myoinositol(600 mg) three times a day; Group II received Metformin 500 mg three times a day. Subjects were advised to try for spontaneous conception. Those who did not conceive after 3 months, were given three cycles of ovulation induction + intrauterine insemination. Hormonal and biochemical profile parameters were done at baseline and after 3 months of therapy. Primary outcome measure was live birth rate. Secondary outcomes were improvement in menstrual cycle, hormonal and biochemical parameters, spontaneous conception, abortions, multiple pregnancy, and ovarian hyperstimulation syndrome. Baseline demographic, hormonal and biochemical parameters were comparable in two groups. There was a significant improvement in menstrual cycles (cycle length and bleeding days) in Group I as compared to Group II. The improvement in biochemical and hormonal parameters were comparable in the two groups after 3 months. Live birth rate was significantly higher in the Group I as compared to Group II [55% (33/60); 26.67% (16/60); p = .002]. The study concluded significantly higher live birth rate in women receiving the combination as compared to metformin alone.

FSHB -211 G>T is a major genetic modulator of reproductive physiology and health in childbearing age women.

FSHB -211 G>T is a major genetic modulator of reproductive physiology and health in childbearing age women.

Reference Intervals: Strengths, Weaknesses, and Challenges.

A reference interval (RI)10 is a standard component of reporting a laboratory result and is important to transform a numerical value into clinically meaningful information. An RI is intended to inform the clinical care provider that laboratory values within the interval indicate a nondiseased condition. The most common approach is to base an RI on the central 95% of laboratory test values observed for a reference population that is free of diseases that influence that laboratory test result. Because many diseases are asymptomatic, it becomes difficult to qualify people for a nondiseased condition, thus biasing the selection of reference individuals. Furthermore, information on the full complement of disease conditions that influence a laboratory test may be unknown. Thus, RIs may be influenced by inappropriately selected reference populations. Another limitation in determining an RI is obtaining an adequate sample of a reference population to make an estimate of the central 95% of results with suitable uncertainty to be meaningful for interpreting a test result. The sample size requirement becomes even larger when partitioning by sex, age, ethnicity, menstrual cycle, and other parameters is necessary for meaningful RIs. CLSI Guideline EP28-A3c describes consensus approaches and some limitations for establishing and verifying RIs. However, some of the approaches in this guideline are statistically underpowered such that uncertainties in the RIs may not be appreciated. A particularly challenging situation is the requirement for laboratories to establish an RI for a laboratory developed measurement procedure (MP) or to verify the RIs proposed by the manufacturer of an in vitro diagnostic (IVD) MP. Identifying a suitable reference population for either requirement can be very challenging. Evolution in laboratory practice is needed to enable appropriate RIs to be adopted by laboratories. We asked experts with different perspectives to address issues we all face in establishing or …

Possibility of phytotherapy for correction of functional stress-induced menstrual disorders

About 80% of women of reproductive age are suffer from menstrual disorders, such as dysmenorrhea, intermenstrual bleeding, irregular menstruation. The main causes of dysregulation of the reproductive system are: significant change in body weight, increased physical activity, nervous and mental strain, smoking, taking medications that affect neurotransmitters and neuromodulators, various endocrinopathies, inflammatory diseases of the sexual sphere, surgery on the ovaries. It was found that menstrual irregularities can be as markers desadaptation on the background of increased psycho-emotional stress. Menstrual disorders require long-term treatment, so it is important to choose not only effective, but also safe, well-tolerated drugs with minimal side effects. To date, these properties have herbal medicines, which greatly expand the treatment of menstrual disorders. The study to examine the effectiveness of the phytodrug normocycle in patients with stress-induced menstrual disorders was performed. The study includes 78 patients aged 17–25 years with functional disorders of the menstrual cycle such as opsomenorrhea (main group). Patients of the main group received the drug normocycle for 3 months. The control group consisted of 40 healthy women of the same age. The effectiveness of the prescribed treatment was studied on the level of mental stress, dynamics of hormonal profile indicators, dynamics of the menstrual cycle parameters, ultrasound picture dynamic. Menstrual cycle returned to normal in more than 70% of women after completion of normocycle therapy. At the same time the drug was well tolerated and there were no side effects of the drug. The study results showed that use of the drug normocycle in women with stress-induced disorders of the menstrual cycle helps to reduce mental stress, stabilize the status of the nervous system that leads to the normalization of hormonal balance and restore the menstruation rhythm. Extending therapy up to 6 months increases the effectiveness of treatment, leads to the restoration of full luteal phase of the menstrual cycle.

Metformin Improves Glucose Effectiveness, Not Insulin Sensitivity: Predicting Treatment Response in Women With Polycystic Ovary Syndrome in an Open-Label, Interventional Study

Although metformin is widely used to improve insulin resistance in women with polycystic ovary syndrome (PCOS), its mechanism of action is complex, with inconsistent effects on insulin sensitivity and variability in treatment response. The aim of the study was to delineate the effect of metformin on glucose and insulin parameters, determine additional treatment outcomes, and predict patients with PCOS who will respond to treatment. We conducted an open-label, interventional study at an academic medical center. Women with PCOS (n = 36) diagnosed by the National Institutes of Health criteria participated in the study. Subjects underwent fasting blood sampling, an IV glucose tolerance test, dual-energy x-ray absorptiometry scan, transvaginal ultrasound, and measurement of human chorionic gonadotropin-stimulated androgen levels before and after 12 weeks of treatment with metformin extended release 1500 mg/d. Interval visits were performed to monitor anthropometric measurements and menstrual cycle parameters. Changes in glucose and insulin parameters, androgen levels, anthropometric measurements, and ovulatory menstrual cycles were evaluated. Insulin sensitivity did not change despite weight loss. Glucose effectiveness (P = .002) and the acute insulin response to glucose (P = .002) increased, and basal glucose levels (P = .001) decreased after metformin treatment. T levels also decreased. Women with improved ovulatory function (61%) had lower baseline T levels and lower baseline and stimulated T and androstenedione levels after metformin treatment (all P < .05). Using an IV glucose tolerance test, which distinguishes improvements in glucose effectiveness and insulin sensitivity, metformin does not improve insulin sensitivity in women with PCOS but does improve glucose effectiveness. The improvement in glucose effectiveness may be partially mediated by decreased glucose levels. T levels also decreased with metformin treatment. Ovulation during metformin treatment was associated with lower baseline T levels and greater T and androstenedione decreases during treatment, but not with insulin or LH levels. Thus, the action of metformin in PCOS primarily affects glucose levels and steroidogenesis, which may be mediated by mechanisms that affect both pathways, such as inhibition of mitochondrial complex I.

Characteristics of the Menstrual Cycle After Discontinuation of Oral Contraceptives

Menstrual cycle function may continue to be altered after discontinuation of oral contraceptives (OC). Few studies have been published on the effects of recent OC use on menstrual cycle parameters; none have examined characteristics of the menstrual flow or the quality of cervical mucus. The purpose of this retrospective matched cohort study is to assess biomarkers of the menstrual cycle after discontinuation of OCs. Among a sample of women who daily recorded observations of menstrual cycle biomarkers, 70 women who had recently discontinued OCs were randomly matched by age and parity with 70 women who had not used OCs for at least 1 year. Outcomes investigated included overall cycle length, length of the luteal phase, estimated day of ovulation, duration of menstrual flow, menstrual intensity, and mucus score. Differences between recent OC users and controls were assessed using random effects modeling. Recent OC users had statistically significantly lower scores for mucus quality for cycles 1 and 2. Additionally, OC users had a later estimated day of ovulation that was statistically significant in cycle 2 and a decreased intensity of menstrual flow that was significant in the first four cycles (difference = -0.48 days). In random effects modeling, all these parameters were significantly different for the first six cycles combined. Menstrual cycle biomarkers are altered for at least two cycles after discontinuation of OCs, and this may help explain the temporary decrease in fecundity associated with recent OC use.

Reproductive characteristics of wild female Phayre's leaf monkeys

Understanding female reproductive characteristics is important for assessing fertility, interpreting female behavior, and designing appropriate conservation and captive management plans. In primate species lacking morphological signs of receptivity, such as most colobines, determination of reproductive parameters depends on the analysis of reproductive hormones. Here, we use fecal hormone analysis to characterize cycle patterns (N=6 females) and gestation length (N=7 females) in a group of wild Phayre's leaf monkeys (Trachypithecus phayrei crepusculus) in Phu Khieo Wildlife Sanctuary, Thailand. We found that both fecal estrogen (fE) and progestin (fP) levels showed clear biological patterns indicative of ovulation and conception. However, because fP patterns were inadequate in determining the end of the luteal phase, we used fE rather than fP patterns to delineate menstrual cycle parameters. We found a mean cycle length of 28.4 days (N=10), with follicular and luteal phases of 15.4 (N=10) and 12.5 days (N=14), respectively. On average, females underwent 3.57 (N=7) cycles until conception. Average gestation length was 205.3 days (N=7), with fE levels increasing over the course of pregnancy. Overall, the reproductive characteristics found for Phayre's leaf monkeys were consistent with results for other colobine species, suggesting that fecal hormone monitoring, particularly for fE metabolites, can provide useful reproductive information for this species.