Consumer wearables and personal devices for tracking the fertile window.

The market for technology that tracks ovulation to promote conception is rapidly expanding in the United States, targeting the growing audience of technologically proficient, reproductive-age female consumers. In this narrative review, 23 different, nonprescription wearables and devices designed to help women track their fertile window were identified as currently, commercially available in the United States. The majority of these utilize measurements of basal body temperature or combinations of various urinary hormones. This clinical opinion characterizes the scant available research validating the accuracy of these technologies. It further examines research oversight, discusses the utility of these wearables and devices to consumers, and considers these technologies through an equity lens. The discussion concludes with a call for innovation, describing promising new technologies that not only harness unique physiologic parameters to predict ovulation, but also focus on cost-effectiveness with the hope of increasing access to these currently costly devices and wearables.

A Comparison of Two Hormonal Fertility Monitoring Systems for Ovulation Detection: A Pilot Study.

Background and Objectives: Accuracy in detecting ovulation and estimating the fertile window in the menstrual cycle is essential for women to avoid or achieve pregnancy. There has been a rapid growth in fertility apps and home ovulation testing kits in recent years. Nevertheless, there lacks information on how well these apps perform in helping users understand their fertility in the menstrual cycle. This pilot study aimed to evaluate and compare the beginning, peak, and length of the fertile window as determined by a new luteinizing hormone (LH) fertility tracking app with the Clearblue Fertility Monitor (CBFM). Materials and Methods: A total of 30 women were randomized into either a quantitative Premom or a qualitative Easy@Home (EAH) LH testing system. The results of the two testing systems were compared with the results from the CBFM over three menstrual cycles of use. Potential LH levels for estimating the beginning of the fertile window were calculated along with user acceptability and satisfaction. Results: The estimates of peak fertility by the Premom and EAH LH testing were highly correlated with the CBFM peak results (R = 0.99, p < 0.001). The participants had higher satisfaction and ease-of-use ratings with the CBFM compared to the Premom and EAH LH testing systems. LH 95% confidence levels for estimating the beginning of the fertile window were provided for both the Premom and EAH LH testing results. Conclusions: Our pilot study findings suggest that the Premom and EAH LH fertility testing app can accurately detect impending ovulation for women and are easy to use at home. However, successful utilization of these low-cost LH testing tools and apps for fertility self-monitoring and family planning needs further evaluation with a large and more diverse population.

Survey Analysis of Quantitative and Qualitative Menstrual Cycle Tracking Technologies.

Background and Objectives: Digital health and personalized medicine are advancing at an unprecedented pace. Users can document their menstrual cycle data in a variety of ways, including smartphone applications (apps), temperature tracking devices, and at-home urine hormone tests. Understanding the needs and goals of women using menstrual cycle tracking technologies is the first step to making these technologies more evidence based. The purpose of this study was to examine the current use of these technologies and explore how they are being used within the context of common hormonal and reproductive disorders, like polycystic ovary syndrome (PCOS), endometriosis, and infertility. Materials and Methods: This was a cross-sectional study evaluating menstrual cycle tracking technology use. Participants were recruited in January-March 2023 using social media groups and a Marquette Method instructor email listserv. Data were collected using an electronic survey with Qualtrics. Data collected included participant demographics, menstrual cycle characteristics, reproductive health history, and menstrual cycle tracking behavior. Results: Three-hundred and sixty-eight participants were included in the analysis. Women had various motivations for tracking their menstrual cycles. Most participants (72.8%) selected "to avoid getting pregnant" as the primary motivation. Three hundred and fifty-six participants (96.7%) reported using a fertility awareness-based method to track and interpret their menstrual cycle data. The Marquette Method, which utilizes urine hormone tracking, was the most frequently used method (n = 274, 68.2%). The most frequently used cycle technology was a urine hormone test or monitor (n = 299, 81.3%), followed by a smartphone app (n = 253, 68.8%), and a temperature tracking device (n = 116, 31.5%). Women with PCOS (63.6%), endometriosis (61.8%), and infertility (75%) in our study reported that the use of tracking technologies aided in the diagnosis. Most participants (87.2%) reported a high degree of satisfaction with their use and that they contributed to their reproductive health knowledge (73.9%). Conclusions: Women in our study reported avoiding pregnancy as their primary motivation for using menstrual cycle tracking technologies, with the most frequently used being a urine hormone test or monitor. Our study results emphasize the need to validate these technologies to support their use for family planning. Given that most women in this study reported using a fertility awareness-based method, the results cannot be generalized to all users of menstrual cycle tracking technologies.

Wearable Sensors Reveal Menses-Driven Changes in Physiology and Enable Prediction of the Fertile Window: Observational Study.

BACKGROUND: Previous research examining physiological changes across the menstrual cycle has considered biological responses to shifting hormones in isolation. Clinical studies, for example, have shown that women's nightly basal body temperature increases from 0.28 to 0.56 ËšC following postovulation progesterone production. Women's resting pulse rate, respiratory rate, and heart rate variability (HRV) are similarly elevated in the luteal phase, whereas skin perfusion decreases significantly following the fertile window's closing. Past research probed only 1 or 2 of these physiological features in a given study, requiring participants to come to a laboratory or hospital clinic multiple times throughout their cycle. Although initially designed for recreational purposes, wearable technology could enable more ambulatory studies of physiological changes across the menstrual cycle. Early research suggests that wearables can detect phase-based shifts in pulse rate and wrist skin temperature (WST). To date, previous work has studied these features separately, with the ability of wearables to accurately pinpoint the fertile window using multiple physiological parameters simultaneously yet unknown. OBJECTIVE: In this study, we probed what phase-based differences a wearable bracelet could detect in users' WST, heart rate, HRV, respiratory rate, and skin perfusion. Drawing on insight from artificial intelligence and machine learning, we then sought to develop an algorithm that could identify the fertile window in real time. METHODS: We conducted a prospective longitudinal study, recruiting 237 conception-seeking Swiss women. Participants wore the Ava bracelet (Ava AG) nightly while sleeping for up to a year or until they became pregnant. In addition to syncing the device to the corresponding smartphone app daily, women also completed an electronic diary about their activities in the past 24 hours. Finally, women took a urinary luteinizing hormone test at several points in a given cycle to determine the close of the fertile window. We assessed phase-based changes in physiological parameters using cross-classified mixed-effects models with random intercepts and random slopes. We then trained a machine learning algorithm to recognize the fertile window. RESULTS: We have demonstrated that wearable technology can detect significant, concurrent phase-based shifts in WST, heart rate, and respiratory rate (all P<.001). HRV and skin perfusion similarly varied across the menstrual cycle (all P<.05), although these effects only trended toward significance following a Bonferroni correction to maintain a family-wise alpha level. Our findings were robust to daily, individual, and cycle-level covariates. Furthermore, we developed a machine learning algorithm that can detect the fertile window with 90% accuracy (95% CI 0.89 to 0.92). CONCLUSIONS: Our contributions highlight the impact of artificial intelligence and machine learning's integration into health care. By monitoring numerous physiological parameters simultaneously, wearable technology uniquely improves upon retrospective methods for fertility awareness and enables the first real-time predictive model of ovulation.

Ovulatory status and menstrual cycle duration assessed by self-collection of urine on pH strips in a population-based sample of French women not using hormonal contraception.

BACKGROUND: Assessing menstrual cycle function in the general population using a non-invasive method is challenging, both in non-industrialized and industrialized countries. SUBJECTS AND METHODS: The Observatory of Fecundity in France (Obseff) recruited on a nationwide basis a random sample of 943 women aged 18-44 years with unprotected intercourse. A sub-study was set up to assess the characteristics of a menstrual cycle by using a non-invasive method adapted to the general population. Voluntary women were sent a collection kit by the post and requested to collect urine samples on pH strips, together with daily recording of reproductive-related information during a full menstrual cycle. A total of 48 women collected urine every day, whereas 160 women collected urine every other day. Immunoassays were used to measure pregnanediol-3-α-glucuronide, estrone-3-glucuronide and creatinine. Ovulation occurrence and follicular phase duration were estimated using ovulation detection algorithms, compared to a gold standard consisting of three external experts in reproductive medicine. RESULTS: Every other day urine collection gave consistent results in terms of ovulation detection with every day collection (intraclass coefficient of correlation, 0.84, 95% confidence interval, 0.76-0.98). The proportion of anovulatory menstrual cycles was 8%. The characteristics of the ovulatory cycles were length 28 (26-34), follicular phase 16 (12-23), luteal phase 13 (10-16) days median (10th-90th percentiles). DISCUSSION-CONCLUSION: Assessing menstrual cycle characteristics based on urine sample spot only collected every other day in population-based studies through a non-invasive, well accepted and cost-limited procedure not requiring any direct contact with the survey team appears feasible and accurate.

Fertility awareness-based mobile application for contraception.

OBJECTIVES: The aim of the study was to retrospectively evaluate the effectiveness of a fertility awareness-based method supported by a mobile-based application to prevent unwanted pregnancies as a method of natural birth control. METHODS: In a retrospective analysis, the application's efficiency as a contraceptive method was examined on data from 4054 women who used the application as contraception for a total of 2085 woman-years. RESULTS: The number of identified unplanned pregnancies was 143 during 2053 woman-years, giving a Pearl Index of 7.0 for typical use. Ten of the pregnancies were due to the application falsely attributing a safe day within the fertile window, producing a perfect-use Pearl Index of 0.5. Calculating the cumulative pregnancy probability by life-table analysis resulted in a pregnancy rate of 7.5% per year (95% confidence interval 5.9%, 9.1% per year). CONCLUSIONS: The application appears to improve the effectiveness of fertility awareness-based methods and can be used to prevent pregnancies if couples consistently protect themselves on fertile days.

The ultrasonographic detection of follicular rupture at the time of intrauterine insemination: is it really decisive?

Our aim is to assess the impact of the ultrasonographic detection of follicular rupture on the intrauterine insemination success. A total of 313 women undergoing ovarian stimulation for intrauterine insemination were enrolled. Transvaginal ultrasonography was performed to check whether the dominant follicle had ruptured and according to that the patients were divided into two groups. The ultrasound detection of follicular rupture was observed in 156 patients (54%). The independent variables favoring follicular rupture were: Age (t: 7.646, p < 0.0005), FSH value (t: -5.637, p < 0.0005), duration of infertility (t: -4.265, p < 0.0005), menstrual cycle length (t: -4.927, p < 0.0005). Moreover, the logistic regression analysis demonstrated that the predictive variables for follicular rupture were: FSH value (OR 1.7, CI 95% 1.3-2.3, p < 0.0005), duration of infertility (OR 2.6, CI 95% 1.6-4.2, p < 0.0005) and menstrual cycle length (OR 2.4, CI 95% 1.7-3.4, p < 0.0005). Pregnancy occurred in 23 patients of the group A (14.7%) and in 22 patients of the group B (16.5%) without a significant difference (p = 0.6). The logistic regression analysis confirmed that neither the evidence of follicular rupture nor any other variables influenced the pregnancy rate.

billingsMentor: Adapting natural family planning to information technology and relieving the user of unnecessary tasks.

BillingsMentor is an automated Web-based service for the Billings Method of natural family planning in which the guidance and interpretation previously communicated from teacher to student is provided by programmed algorithms. There are two functions: (1) to instruct the client to generate proper descriptions of her fertility symptoms; and (2) to interpret the symptoms efficiently according to the Billings Method and to communicate the results to the client. The efficiency of billingsMentor was tested by using the historical records of students who were under the guidance of a teacher to emulate their experience under the guidance of billingsMentor. The results indicate that billingsMentor performs as well as the teacher/student in recognizing the peak of fertility but it is slightly less efficient than the teacher/student in establishing the basic infertile pattern. Advantages that arise from adapting natural family planning to information technology are discussed.

Switching from cetrorelix to dydrogesterone in an IVF cycle - a new strategy for unexpected freeze-all cycles.

Preventing a luteinizing hormone (LH) surge is a major concern in controlled ovarian stimulation (COS). Several strategies have been developed over the years, including protocols with Gonadotrophin Releasing Hormone agonists and antagonists. More recently Progestin Primmed Ovarian Stimulation (PPOS) has shown to be equally effective in pituitary suppression, with comparable clinical and laboratorial outcomes. This is the case of a 34 year old female, with a previous diagnosis of primary infertility due to tubal factor and high ovarian reserve markers. The initial plan was to perform IVF/ICSI. followed by fresh blastocyst transfer. The chosen COS strategy was to use Alfacorifolitropin 150mg (Elonva®) and Cetrorelix acetate 0,25mg (Cetrotide®) in a flexible pituitary suppression protocol. However, because of elevated risk for Ovarian Hyper-stimulation Syndrome (OHSS) detected during ultrasound and hormonal monitoring, in order to diminish financial burden and to have a more patient friendly protocol, we switched cetrorelix acetate to oral dydrogesterone. COS was successful and resulted in 24 retrieved oocytes (16 metaphase 2 oocytes) without any premature LH peak. No OHSS symptoms occurred. Our main goal with this case report is to reinforce the feasibility and efficacy of this innovative approach, especially in patients aiming for a fresh embryo transfer, who present alert sings of OHSS during the stimulation. Developing friendlier and cheaper protocols in assisted reproduction makes the treatment more accessible and affordable.

Ovulatory status of overweight women without Polycystic Ovary Syndrome.

OBJECTIVE: Obesity is one of the extra hypothalamic-pituitary-ovarian axis factors that can influence ovulation. The isolated impact of obesity on ovulation without other comorbidities needs to be further studied. Our goal is to evaluate the association between the anovulation in the ultrasonographic monitoring of the ovulation cycle and the body mass increase of infertile patients without polycystic ovaries of a university service. METHODS: Case-control study performed at the Human Reproduction Laboratory of the University Hospital. We evaluated 1,356 ultrasound monitoring reports of ovulation between January 2011 and December 2015. We named case those patients who ovulated on the monitored cycle. After applying the exclusion criteria, we consolidated a total of 110 cases and 118 controls. The exposure variables were normal BMI or patients classified with a BMI above normal. Data analysis was performed using SPSS 22.0. Differences in proportions were assessed by X2 test Pearson, Fisher and Wilcoxon test. The value of p<0.05 was considered statistically significant. RESULTS: The groups were comparable in age, age at menarche, number of pregnancies, deliveries, cesarean sections and abortions, number of antral follicles, FSH, prolactin and TSH values. Among the anovulatory patients, 57 (51.82%) were overweight, while among ovulatory patients, 44 (37.29%) were in this same BMI category. The odds ratio was 1.8655, with a significant p value (p<0.05). CONCLUSION: There was an association between anovulation and increase in the Body Mass Index, with an increased risk of anovulation in patients with BMI above normal.

Towards the Clinical Evaluation of the Luteal Phase in Fertile Women: A Preliminary Study of Normative Urinary Hormone Profiles.

Objective: To describe and evaluate urinary hormone profiles in the luteal phase. Setting and Patients: Twenty-five healthy fertile women, with regular ovulatory pattern cycles as assessed by temperature and cervical mucus, at a university based center. Methods: Daily urinary hormonal assessment of luteinizing hormone, estrone glucuronide, and pregnanediol glucuronide. This was done during 3 or more cycles, with 78 completed cycles. Samples were analyzed by both crude levels and levels adjusted for the hormone excretion rate. Correlation between measured parameters (LH surge, vulvar mucus) was assessed with regard to their ability to detect presumed ovulation. Results: An upper, middle, and lower tercile range for the main urinary reproductive hormones was determined and a classification system of zones proposed, considering profiles over or under the 10th percentile. Adjustment for the urine excretion rate proved useful for interpreting individual samples; this was less necessary with multiple samples over time where trends could be determined. This serial evaluation, in at least two cycles, lowered the possibility of finding an isolated luteal phase defect and helped identify the recurrence of such. Vulvar mucus findings performed well in determining the timing of ovulation. Despite the proven fertility of the study population, lower luteal phase hormones were detected in both an isolated and, in some situations, recurrent manner. Conclusion: A feasible method is proposed to accurately, thoroughly and reproducibly study the luteal phase in order to evaluate and treat identified abnormalities in a properly timed, restorative manner. This preliminary study provides the basis for future research, correlating urinary hormones with clinical findings, particularly those of luteal phase defects.

Detection of ovulation, a review of currently available methods.

The ability to identify the precise time of ovulation is important for women who want to plan conception or practice contraception. Here, we review the current literature on various methods for detecting ovulation including a review of point-of-care device technology. We incorporate an examination of methods to detect ovulation that have been developed and practiced for decades and analyze the indications and limitations of each-transvaginal ultrasonography, urinary luteinizing hormone detection, serum progesterone and urinary pregnanediol 3-glucuronide detection, urinary follicular stimulating hormone detection, basal body temperature monitoring, and cervical mucus and salivary ferning analysis. Some point-of-care ovulation detection devices have been developed and commercialized based on these methods, however previous research was limited by small sample size and an inconsistent standard reference to true ovulation.

Patients' auto report of regularity of their menstrual cycles. Medical history is very reliable to predict ovulation. A cross-sectional study.

OBJECTIVE: Infertility of ovulatory cause can account for a quarter of infertility etiologies and one of the questions in the patients' clinical history is about their self-perception of the regularity of their menstrual cycles. The aim of this study was to assess whether the information on menstrual regularity is consistent with the assessment of the presence or absence of ovulation. METHODS: Cross-sectional study. The inclusion criteria were: patients with infertility for at least one year, complete examination and ovulation monitoring, aged between 18 and 38 years completed. The patients were divided into two paired groups: those who reported regular menstrual cycles and those who reported irregular cycles. In the ultrasonographic monitoring of ovulation we separated those who ovulated from those who did not ovulate, and applied the Fischer's test. RESULTS: Among the 199 patients who reported having regular menstrual cycles, 113 had proven ovulation upon ultrasound monitoring and 86 patients did not ovulate. Among the 29 patients who reported irregular cycles, 24 did not ovulated at the cycle monitoring. The Fisher's exact test was applied and the p-value found was significant. CONCLUSION: The story of the patient in the clinical interview about the presence of regular or irregular menstruation correlates with the presence or absence of ovulation, it should be taken into consideration in the reasoning regarding the infertility etiology. This report would be important to guide the patient's ovulatory regularity diagnosis.

Método de Ovulação Billings: entre eficácia e desconhecimento / Billings Ovulation Method: between efficacy and lack of knowledge / Método de Ovulación Billings: entre la eficacia y el desconocimiento

Resumo Apesar dos grandes investimentos, os métodos artificiais de planejamento familiar ainda apresentam limitações. Desde a década de 1950, cientistas trabalham para desenvolver um método natural confiável. Este artigo revisa a literatura sobre o Método de Ovulação Billings, apontando sua lógica, sua eficácia, seus benefícios, seus desafios e suas regras. Trata-se de método natural, embasado em mais de cinquenta anos de pesquisas. Sua chave de leitura é o muco cervical, confiável indicador da fertilidade, e sua eficácia está entre 97% e 99%, comparável aos métodos mais eficazes. O método também é indicado para todo tipo de ciclo, pois não se baseia em cálculos, e sim na observação do muco. Conclui-se que no Brasil é preciso fortalecer programas que ofereçam educação sexual mais global à população, capacitando ainda profissionais da saúde a respeito dos métodos naturais de planejamento familiar.

Abstract Despite large investments, artificial family planning methods still have limitations. Since the 1950s, scientists have worked to develop a reliable natural method. This article reviews the literature on the Billings Ovulation Method, pointing out its logic, efficacy, benefits, challenges, and rules. It is a natural method, based on more than fifty years of research. Its reading key is the cervical mucus, a reliable indicator of fertility, and its efficacy is between 97 and 99%, comparable to most effective methods. Billings is also suitable for all types of cycles, as it is not based on calculations, but on the observation of the mucus. In conclusion, Brazil needs to strengthen programs that offer more global sexual education to the population, also training health professionals on natural family planning methods.

Resumen A pesar de las grandes inversiones, los métodos artificiales de planificación familiar todavía tienen limitaciones. Desde la década de 1950, los científicos vienen trabajando para desarrollar un método natural confiable. Este artículo revisa la literatura sobre el Método de Ovulación Billings, presentando su lógica, efectividad, beneficios, desafíos y reglas. Se trata de un método natural, basado en más de cincuenta años de investigación. Su clave es el moco cervical, un indicador confiable de fertilidad, y su efectividad está entre el 97% y el 99%, comparable a los métodos más efectivos. El Método de Ovulación Billings también es adecuado para todo tipo de ciclos, ya que no se fundamenta en cálculos, sino en la observación de mocos. Se concluye que en Brasil es necesario fortalecer programas que ofrezcan una educación sexual más global a la población, además de capacitar a los profesionales de la salud sobre métodos naturales de planificación familiar.

A Feasibility Study of Women's Confidence and Comfort in Use of a Kit to Monitor Ovulation.

INTRODUCTION: The focus of this study was to examine whether low-income adult women will use ovulation test strips, a menstrual calendar chart, thermometer, temperature graph, and cervical mucus assessment to monitor their ovulation time and other menstrual changes. Women's confidence in their ability to detect ovulation time and understand the menstrual cycle changes were also examined. METHODS: This is a descriptive study. Twenty-two low-income women aged 18 to 39 years living in medically underserved neighborhoods participated in this study. The women were introduced to and taught how to use a knowing your body (KB) kit, which consisted of ovulation test strips, monthly calendars for menstrual logs, digital thermometer for basal body temperature, and graphs to chart temperature. The women were interviewed 6 to 8 weeks later to confirm their experiences with the use of the KB kit. RESULTS: Ninety-one percent of the women used the ovulation test strips (mean, 3.8 strips); 77.3% were very to extremely confident that they could properly use the ovulation strip, 54.6% knew when they ovulated, and 31.8% could use the thermometer to confirm when they were ovulating. Seventy-three percent of the women were very to extremely comfortable using the ovulation test strips, 81.8% using the thermometer, 45.5% using the temperature graph, and 31.8% using the TwoDay Method (cervical mucus observation). DISCUSSION: The use of the ovulation test strip and other content of the KB kit provides a new opportunity for low-income women to learn about their bodies by monitoring their ovulation time and other menstrual changes as a pregnancy planning and early pregnancy recognition tool.

Detection of ovulation by a radioreceptor assay for human luteinizing hormone.

A specific, sensitive, and rapid radioreceptor assay (RRA), employing membranes from bovine testes as receptor and [125I]hLH as radioligand, has been developed for measurement of human LH in serum. This RRA was used to determine the time of ovulation in seven women. For comparison, four hourly values around midcycle were measured by RIA. The sensitivity of the RRA was 0.78 ng/ml serum and could be increased by prolonged incubation. The coefficient of within and between assay variation at the 50% inhibition level was 7% and 13%, respectively. The mean index of discrimination (RRA/RIA) was 1.02, expressed by the slope of the regression curve. The coefficient of correlation was 0.97. In all women, the LH surge was detected by RRA, and the subsequent ovulation was verified within 30 h by endoscopic examination of the ovaries, as well as serum progesterone concentrations of more than 5 ng/ml on the fifth day after ovulation. As shown, prospective ovulation timing can be done by this simple and accurate method. The RRA can be useful in infertility therapy such as artificial insemination.

PIP: A 2-hour solid-phase radioimmunoassay (RIA) is described for determination of luteinizing hormone (LH) concentrations to detect ovulation. Time of ovulation was determined in 7 women. For comparison, 4 hourly values around midcycle were measured by 2-hour RIA. The 2-hour RIA sensitivity was .78 ng/ml of serum and could be increased by prolonged incubation. The coefficients of within and between assay variation at the 50% inhibition level were 7 and 13%, respectively. The mean index of discrimination between standard RIA and 2-hour RIA was 1.02, expressed by the slope of the regression curve. The coefficient of correlation was .97. In all women, the LH surge was detected by 2-hour RIA, and the subsequent ovulation was verified within 30 hours by endoscopic examination of ovaries as well as serum progesterone concentrations of more than 5 ng/ml on the 5th day after ovulation. Prospective ovulation timing can be done by this simple, accurate method. The 2-hour RIA can be useful in infertility therapy such as artificial insemination.

A model to detect interactions between roxithromycin and oral contraceptives.

Twenty-two healthy women participated in a study to determine whether roxithromycin (a new macrolide antibiotic agent) obtunds the activity of a triphasic oral contraceptive. The duration of the study was four menstrual cycles. Medication was given as follows: (1) cycle 1, no medication to demonstrate ovulation; (2) cycle 2, triphasic oral contraceptive daily to suppress ovulation; (3) cycle 3, triphasic oral contraceptive daily plus roxithromycin, 150 mg b.i.d.; and (4) cycle 4, triphasic oral contraceptive daily plus rifampin, 300 mg daily. Sonography of the ovaries was performed on day 13, and serum progesterone was measured on day 21 of each cycle. Elevated progesterone indicated ovulation. The presence of a maturing follicle supported this finding. All volunteers ovulated in the first cycle and no volunteers ovulated in the second and third cycles. However, 11 women ovulated when rifampin and the triphasic oral contraceptive were given concomitantly. The findings suggest there is no reason to believe that roxithromycin interferes with the efficacy of oral contraceptives.

On differences between the preovulatory luteinizing hormone surges of 4- and 5-day cyclic rats.

Preovulatory LH surges were studied in rats with ovarian cycles of 4 days (4d-rats) and 5 days (5d-rats). In 5d-rats the maximal peak height was about twice that observed in 4d-rats, whereas in 4d-rats peaks occurred about 1-5 h later than in 5d-rats and were much less consistently timed. From experiments in which LH releasing hormone (LH-RH) was infused into pentobarbitone-blocked pro-oestrous rats, it was concluded that (a) differences between the two types of preovulatory LH surges originate within the central nervous system, and (b) pro-oestrous LH-RH secretion may not be restricted to the period in which increased LH levels in blood were found, but may exceed this period for a considerable time.

PIP: Preovulatory luteinizing hormone (LH) surges were studied in rats with ovarian cycles of 4 days and 5 days as well as the pituitary responses of pentobarbitone-blocked, proestrous 4- and 5-day rats to a continuous infusion of LH-releasing Hormone (LH-RH). Plasma LH was measured by double-antibody radioimmunoassay. Ovulatory response was verified by the presence of ova in the oviducts of sacrificed rats. In 5-day rats the maximum LH peak was twice that observed in 4-day rats. However, in 4-day rats the peaks occurred 1.5 hours later than in 5-day rats and were much less consistently timed. The course of plasma LH levels of individual 4- and 5-day rats during continuous LH-RH infusion, showed a sharp rise initially declining sharply within 2 hours. It is concluded that differences between the 2 types of preovulatory LH surges originate within the central nervous system and the proestrous LH-RH secretion may not be restricted to the period in which increased LH levels in blood were found, but may exceed this period for a considerable time.

Sialic acid concentration in the reproductive organs, pituitary gland and urine of the Indian langur monkey (Presbytis entellus entellus).

The concentration of sialic acid was determined in the reproductive organs, pituitary gland and urine of male and female langur monkeys. In the male, sialic acid concentration was lowest in the testes and highest in the epididymides. Both caput and cauda epididymides contained almost the same concentration. Castration and subsequent androgen administration did not modify the concentration of sialic acid by comparison with intact animals, suggesting that sialic acid is not androgen-dependent in the langur. There was no significant difference in sialic acid concentration in the uterus during the proliferative and luteal phases of the menstrual cycle. After ovariectomy, there was a decrease in the concentration of sialic acid in the uterus, cervix and vagina while oestrogen or oestrogen plus progesterone administration increased its concentration significantly, but not to the control level. However, the difference in concentration between oestrogen-treated and oestrogen plus progesterone-treated monkeys was not significant. There was a peak of sialic acid excretion in the urine on day 8 of the normal 22-day menstrual cycle, i.e. a day before the probable day of ovulation. In pregnant monkeys siliac acid excretion increased significantly 2 days before delivery compared with the values recorded 7 to 3 days before parturition. The part played by sialic acid during the menstrual cycle and pregnancy in the female is not clear.

PIP: The distribution of sialic acid in the genital organs, pituitary gland, and urine of langur monkeys was studied to determine: 1) whether it may help to pinpoint the day of ovulation, 2) whether the circulating levels of steroid hormones affect sialic acid concentration, and 3) its concentration during pregnancy. In the male the concentration was lowest in the testes and highest in the epididymides. The same concentration was found in the caput and cauda epididymides. Castration and androgen failed to modify the concentration of sialic acid in comparison with intact animals which suggests that sialic acid is not androgen-dependent in the langur. There was a lack of significant difference in sialic acid concentration in the uterus during proliferative and luteal phases of the menstrual cycle. There was a decrease in the concentration of sialic acid in the uterus, cervix, and vagina after ovariectomy. Estrogen or estrogen plus progesterone increased its concentration but not to the control level. There was a peak of sialic acid excretion on Day 8 of the 22-day menstrual cycle. Sialic acid excretion increased significantly 2 days before delivery in pregnant monkeys.

Buserelin. A review of its pharmacodynamic and pharmacokinetic properties, and clinical profile.

The gonadotrophin releasing hormone (GnRH) [luteinising hormone-releasing hormone (LHRH); gonadorelin] agonist buserelin is a promising new agent in the treatment of a variety of disorders in gynaecology and andrology, paediatrics and oncology. While a single dose of buserelin stimulates the release of pituitary gonadotrophins, multiple doses produce reversible pituitary desensitisation, and this specific blockade of gonadotrophin support to the gonads provides the basis for the drug's efficacy in conditions dependent on sex hormone secretion. Thus, buserelin provides comparable efficacy to orchidectomy or high dose estrogens in the treatment of hormone-sensitive prostate cancer and exhibits a lower incidence of adverse effects. During the early phase of treatment it may be particularly useful in combination with antiandrogens. Buserelin also appears promising in hormone-sensitive premenopausal breast cancer. Extensive studies have proven the value of buserelin in endometriosis, where it produces a transient remission with gradual recurrence of the disease on cessation of treatment. Surgical intervention is necessary in severe disease after buserelin-induced involution of the lesions. In patients with uterine leiomyoma, preliminary data suggest that buserelin may be beneficial in rendering surgery more conservative by reducing fibroid size, although it appears unlikely to preclude surgical intervention. The use of buserelin to induce a state of reversible hypogonadotrophism before administration of exogenous gonadotrophins is a promising strategy in the treatment of infertility associated with polycystic ovary syndrome and other conditions of infertility with underlying ovarian dysfunction; such a strategy also clearly enhances the efficiency of in vitro fertilisation programmes. Initial studies suggest its potential usefulness as a female contraceptive when administered intermittently in conjunction with a progestogen. Buserelin represents a first-line treatment of central precocious puberty. In endometriosis the adverse effect profile of buserelin is generally favourable, with hypoestrogenic effects such as hot flushes and vaginal dryness, and decreased libido, predominating. There is no apparent detrimental effect on lipid metabolism. The potential for adverse hypoestrogenic effects on bone mineral content with long term administration remains to be clarified. Thus, the GnRH agonist buserelin represents an advance in the treatment of a variety of gynaecological and andrological as well as paediatric and oncological conditions, infertility and other sex-hormone dependent conditions, with a low incidence of adverse treatment effects.