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PubMed2000

Cardiovascular disease in women with polycystic ovary syndrome at long-term follow-up: a retrospective cohort study.

OBJECTIVE: Polycystic ovary syndrome (PCOS) is associated with higher prevalence of cardiovascular risk factors but the relative prevalence of cardiovascular disease in women with PCOS has not previously been reported. We have compared cardiovascular mortality and morbidity in middle-aged women previously diagnosed with PCOS and age-matched control women. DESIGN: A retrospective cohort study of women diagnosed with PCOS in the United Kingdom before 1979. PATIENTS: Seventy cohort members died before 31 March 1999. Morbidity data were collected from 319 women with PCOS and 1060 age-matched control women. Sixty-one women with PCOS and 63 control women attended a clinical examination. MEASUREMENTS: Data were collected from death certificates, general practitioners' records and questionnaires with measurement of cardiovascular risk factors in a subsample of questionnaire respondents. RESULTS: All-cause and cardiovascular mortality in the cohort were similar to women in the general population (standardized mortality ratios (95% CI): 93 (72-117) and 78 (45-124), respectively). Women with PCOS had higher levels of several cardiovascular risk factors: diabetes (P = 0.002) hypertension (P = 0.04), hypercholesterolaemia (P < 0.001), hypertriglyceridaemia (P = 0.02) and increased waist:hip ratio (P = 0.004). After adjustment for BMI, odds ratios (OR) were 2.2 (0.9-5. 2) for diabetes, 1.4 (0.9-2.0) for hypertension and 3.2 (1.7-6.0) for hypercholesterolaemia. A history of coronary heart disease (CHD) was not significantly more common in women with PCOS (crude OR (95%CI) 1.5 (0.7-2.9)) but the crude OR for cerebrovascular disease was 2.8 (1.1-7.1). CONCLUSION: At long-term follow-up, a history of nonfatal cerebrovascular disease and cardiovascular risk factors including diabetes are more prevalent among women with polycystic ovary syndrome. Morbidity and mortality from of coronary heart disease among women with polycystic ovary syndrome is not as high as previously predicted. This finding challenges our understanding of the aetiology of coronary heart disease in women.

Aged↗

PubMed2004

[Metformin, an efficacious drug in the treatment of polycystic ovary syndrome].

BACKGROUND AND OBJECTIVE: Polycystic ovary syndrome (PCOS), with an incidence of 5% in women of reproductive age, is defined as the presence of oligo- or amenorrhea in combination with hyperandrogenism. Most patients also suffer from impaired insulin action (insulin resistance). PCOS thus resembles the metabolic syndrome (type 2 diabetes mellitus, hypertension, lipid disorders, atherosclerosis). International studies showed a beneficial effect of metformin treatment on biochemical and reproductive parameters in PCOS. The aim of our study is the evaluation of metformin treatment in a German PCOS sample. PATIENTS AND METHODS: 103 PCOS women (age 18-40) were treated, according to their body weight, with either 1000 mg or 1700 mg metformin per day after assessment of insulin resistance. Clinical features as well as endocrine and metabolic parameters were recorded at baseline and at 1, 6, and 12 months of treatment. Additionally, baseline data were compared with those of 98 control subjects (age 18-38). RESULTS: PCOS women showed significantly higher body mass index, body fat mass and androgen levels, as well as an impaired glucose- and insulin metabolism compared to controls. Metformin treatment ameliorated acne (36% to 4%), hirsutism-score (11.2 to 9.7) and restarted normal menstrual cycles in 66.7% of PCOS-women. Sixteen of 48 patients with unfulfilled wish to conceive became pregnant during therapy. Metformin restored menses in all previously amenorrheic women. Comparing post-metformin versus baseline levels, HOMA-IR (4.6 to 2.3), AUC-I (379 to 225) and 2-h glucose (117 to 90 mg/dl) decreased significantly. Furthermore, metformin decreased testosterone (2.9 to 1.8 nmol/l), free androgen index (9.1 to 5.3) and dehydroepiandrosterone levels (5.1 to 3.9 mg/l). CONCLUSION: Metformin improves significantly hyperandrogenism and insulin resistance in PCOS patients and appears to be an efficacious mode of therapy.

Adolescent↗

PubMed2005

Clinical and biochemical characterization of women with polycystic ovary syndrome in North Rhine-Westphalia.

Polycystic ovary syndrome (PCOS), defined as the combination of oligoanovulation and hyperandrogenism, affects more than 5% of women of reproductive age. Insulin resistance and hyperinsulinemia appear to play an important role in its pathogenesis. Here, we will present a characterization of a PCOS cohort from North Rhine-Westphalia in Germany. Clinical features, family history as well as endocrine and metabolic parameters were prospectively recorded from 200 successive patients. All patients were evaluated for insulin resistance and beta-cell-function by oral glucose tolerance test. Patient data were compared with those of 98 age-matched control women. PCOS patients showed significantly higher BMI, body fat mass and androgen levels as well as impaired glucose and insulin metabolism. A positive family history of PCOS and diabetes was more frequent in PCOS patients. Insulin resistance (71%) was the most common metabolic abnormality in PCOS patients followed by obesity (52%) and dyslipidemia (46.3%), with an incidence of 31.5% for the metabolic syndrome. C-reactive protein and other cardiovascular risk factors were frequently elevated even in young PCOS patients. While the clinical characteristics and endocrine parameters of this German PCOS cohort were heterogeneous, they were comparable to those from other Caucasian populations.

Adult↗

PubMed1997

Role of growth hormone in polycystic ovarian syndrome.

Given recent in-vitro and in-vivo evidence that insulin and growth hormone may have gonadotropin-augmenting effects, the putative endocrine role of serum growth hormone levels in women with polycystic ovarian syndrome (PCOS) has been investigated in several studies since 1990. Obesity is a disease entity in its own right and, therefore, a confounding influence on investigations of PCOS. PCOS in the absence of obesity may be viewed as the "authentic syndrome". The use of IGF-1 as a marker of growth hormone secretion is not fully adequate as there is little to no correlation between this peptide and growth hormone in women with PCOS. The development of hyposomatotropinism in obese PCOS women appears to be an obesity-dependent event. The confirmed observation in both obese and lean women with and without PCOS of serum IGF-1 and IGFBP-3 levels requires further delineation. Preliminary evidence suggest that GH may play a role in the lean woman with PCOS and that the presence of obesity dampens its effect. Future investigations of the role of growth hormone in PCOS are dependent on first elucidating the role of GH in adult women and in the disease state of obesity.

Adult↗

PubMed2001

Early metabolic abnormalities in adolescent girls with polycystic ovarian syndrome.

OBJECTIVE: To investigate insulin sensitivity and secretion in young adolescent girls with childhood onset polycystic ovarian syndrome (PCOS) and to identify the early metabolic derangement(s). STUDY DESIGN: Twelve obese girls with PCOS (age 12.0+/-0.7 years) were compared with 10 obese nonhyperandrogenic girls (control group). The groups were matched for age, percent body fat, and abdominal fat. All subjects underwent a 3-hour hyperinsulinemic (80 mu/m(2)/min)-euglycemic clamp to determine in vivo insulin sensitivity and a 2-hour hyperglycemic clamp (225 mg/dL) to determine insulin secretion. Fasting hepatic glucose production was determined with the use of [6,6-(2)H(2)]glucose. RESULTS: Fasting glucose and hepatic glucose production were comparable between the 2 groups, but fasting insulin was 2-fold higher in the PCOS group. The fasting glucose to insulin ratio was lower in the PCOS group versus the control group (1.9+/- 0.3 vs 3.1+/-0.3, P =.02). During the hyperinsulinemic-euglycemic clamp, insulin sensitivity was lower in the PCOS group (1.4+/-0.2 vs 2.7+/-0.3 mg/kg/min per microu/mL, P =.002). During the hyperglycemic clamp, insulin secretion was significantly higher in the PCOS group. Insulin sensitivity correlated negatively with fasting insulin (r = -0.71, P =.0002) and positively with the fasting glucose to insulin ratio (r = 0.79, P<.0001). CONCLUSION: Adolescent girls with PCOS have profound metabolic derangements detected early in the course of the syndrome, including (1) approximately 50% reduction in peripheral tissue insulin sensitivity, (2) evidence of hepatic insulin resistance, and (3) compensatory hyperinsulinemia. These observations may predict an increased risk of type 2 diabetes mellitus in adolescents with PCOS.

Adolescent↗

PubMed2003

The effect of polycystic ovary syndrome on health-related quality of life.

This article reviews current literature regarding polycystic ovary syndrome (PCOS) and health-related quality of life (HRQoL), as well as examining how some of the manifestations of PCOS affect HRQoL. The only quantitative study was performed in adolescent girls. It used a well-validated instrument and showed that HRQol was worse in those with PCOS in the areas of general health perceptions, behavior, physical functioning and family activity. No comparable study exists for adults with PCOS. However, qualitative psychological studies have demonstrated higher levels of depression, psychological and psychosexual morbidity and an increased response to stress in women with PCOS compared with controls. Low self-esteem, decreased social activity and less romantic contentment were reported in women with PCOS. Weight and hirsutism consistently caused more concern than menstrual problems or infertility. The symptoms associated with PCOS, namely hirsutism, acne, diabetes mellitus and obstructive sleep apnea syndrome (OSAS) were all reported to reduce HRQoL in separate studies. Encouragingly, treatment for acne and OSAS improved the HRQoL, although treatment for hirsutism did not. Quantitative studies on the effect of PCOS on HRQoL and the benefit of treatments need to be conducted.

Female↗

PubMed2003

Insulin resistance and lipid profile in women with polycystic appearing ovaries: implications with regard to polycystic ovary syndrome.

The aim of this study was to investigate carbohydrate and lipid profiles in women with polycystic appearing ovaries (PCO) on ultrasound examination who did not fulfill the criteria for polycystic ovary syndrome (PCOS). We sonographically evaluated and biochemically diagnosed 35 patients with PCO, 31 women with PCOS and 23 healthy controls. We performed oral glucose tolerance tests (OGTT) and calculated the quantitative insulin sensitivity check index (QUICKI) and the homeostatic model assessment (HOMAIR) scores. Serum fasting insulin levels, 1-h insulin response, HOMAIR and QUICKI scores were significantly higher in the PCO and PCOS groups than in the controls. However, serum fasting glucose levels, fasting insulin levels, HOMAIR and QUICKI scores were similar in women with PCO and PCOS. In women with PCO, high-density lipoprotein (HDL) levels were higher, and very-low-density lipoprotein (VLDL) and triglyceride levels were lower compared with women with PCOS. Furthermore, insulin responses to OGTT, HOMAIR and QUICKI scores and lipid values correlated with serum androgen levels and body mass index (BMI) in PCO patients. In conclusion, women with PCO who do not fulfill the criteria for PCOS have abnormal insulin sensitivity and insulin resistance. The finding of similar insulin abnormalities in women with PCO to those in women with PCOS confirms that women with PCO have similar metabolic characteristics to those with PCOS.

Adolescent↗

PubMed2003

The effectiveness of the interview for predicting the presence of polycystic ovary syndrome.

Polycystic ovary syndrome (PCOS), a leading cause of female infertility, occurs in approximately 4% of women of reproductive age. Multifamily studies have established that PCOS has strong inherited traits. Although diagnosis of PCOS in the relatives of affected women can readily be made by clinical and biochemical evaluations, these methods are costly and laborious. The aim of this investigation was to determine whether clinically evident PCOS could be detected by a written questionnaire, which is a significantly less expensive means of detection than direct determination. A questionnaire about the history of possible androgenic symptoms of PCOS was presented to patients and their first-degree female relatives, who were also evaluated by physical and laboratory examinations. The sensitivity, specificity, and positive predictive value (PPV) and negative predictive value (NPV) for the detection of PCOS by interview were calculated. The NPV of the proband interview was significantly lower for sisters than for mothers (82% vs. 100%, respectively; p < 0.05). When the family member completed the written questionnaire directly, the specificity and NPV of self-reporting were equally high (> 90%) for both mothers and sisters. Thus direct interviewing of PCOS patients or their mothers and sisters reliably predicts affected status, but patient interview alone will not predict PCOS in almost 50% of the affected sisters.

Adult↗

PubMed2004

Impaired cholecystokinin secretion and disturbed appetite regulation in women with polycystic ovary syndrome.

Increased amount of abdominal fat and obesity are common in polycystic ovary syndrome (PCOS). A higher prevalence of bulimia nervosa and greater cravings for sweets have also been reported in these patients. The present study aimed to compare meal-related appetite and secretion of the 'satiety peptide' cholecystokinin (CCK) and glucose regulatory hormones in PCOS women and controls. Sixteen pairs of women with PCOS and controls matched for age and body mass index participated in the study. After an overnight fast, blood samples were collected during ingestion of a standardized meal. We determined basal and postprandial blood levels of CCK, insulin, C-peptide, glucagon, cortisol, growth hormone and glucose. Self-ratings of appetite were assessed by a visual analog scale. PCOS women had a significantly lower meal-related CCK response (p < 0.05) with no association with satiety, as in the controls (r = 0.64). There was a tendency to higher ratings of craving for sweets in PCOS women (p = 0.07) but no correlation with insulin, as in the controls (r = 0.50). Within the PCOS group, ratings of craving for sweets were inversely related to testosterone (r = - 0.60) and the CCK response was positively correlated with levels of free testosterone (r = 0.50). We conclude that women with PCOS have reduced postprandial CCK secretion and deranged appetite regulation associated with increased levels of testosterone. Impaired CCK secretion may play a role in the greater frequency of binge eating and overweight in women with PCOS.

Adult↗

PubMed2005

Screening for insulin resistance in women with polycystic ovarian syndrome.

INTRODUCTION: Insulin resistance is implicated in the pathogenesis of polycystic ovarian syndrome (PCOS). Insulin-sensitizing agents are increasingly used in the treatment of infertility and hirsutism in PCOS. However, not all women with PCOS are insulin-resistant. OBJECTIVE: To assess the degree of insulin resistance within a clinic population of women referred for treatment of oligomenorrhoea or infertility. DESIGN: We evaluated 25 consecutive PCOS outpatients referred for treatment of menstrual dysfunction/infertility and a matched control group. All underwent a standard oral glucose tolerance test (OGTT) with serial insulin measurements. Insulin sensitivity was calculated using homeostasis model assessment (HOMA). RESULTS: Five of the 25 clinic patients had abnormal glucose handling (two had previously unknown type 2 diabetes and three had impaired glucose tolerance). Fasting and 2-h insulin levels were significantly higher in the PCOS women. Mean HOMA-S (insulin sensitivity) was even lower for PCOS women with normal GTT status (mean (95% confidence interval): 0.53 (0.34-0.72)) than for controls (0.94 (0.84-1.04)) (F = 4.2, p < 0.001). HOMA-B (pancreatic beta-cell function) was nearly tripled for normal GTT status PCOS women at 273 (205-342) versus 105 (70-139) for controls (F = 6.8, p < 0.001). CONCLUSIONS: The results suggest a role for routine measurement of HOMA-S in identifying women with PCOS with insulin resistance with a view to targeting them with insulin-sensitizing agents.

Adolescent↗

PubMed2004

Developing research management and governance capacity in primary care organizations: transferable learning from a qualitative evaluation of UK pilot sites.

BACKGROUND: The capacity and capabilities for undertaking primary care research have increased both within and outside of the UK in recent years. The UK Department of Health aims to facilitate this further by establishing a national network of primary care organizations (PCOs) ready to act as hosts for shared research governance systems. However, it is unclear which models offer the most effective option. In addition, there is confusion over new processes and concern that researchers may be deterred from addressing important questions. OBJECTIVES: The research ascertains how PCOs selected as pilot sites have organized research management and governance (RM&G). METHODS: We adopted a case study approach involving interviews with key informants in a purposive sample of eight pilot PCO (RM&G) sites. RESULTS: Motivating factors for PCOs to host RM&G included the possibility of additional resources and more effective use of research to improve service delivery. A range of organizational models were adopted, often reflecting existing strategic alliances. It is envisaged that it will not be effective or cost-effective for many PCOs to make individual arrangements for RM&G, and so models are already developing among groups of PCOs and partner organizations. The extent of partnerships between PCOs varied with concern over critical mass and dilution of expertise in larger groupings. The development and implementation of systems in pilot sites was facilitated by the support of the wider PCO in recognizing research as a valued and integral part of the organization; the effective management of relationships and the establishment of equal partnership arrangements for RM&G, and the effective use of existing R&D infrastructure and expertise. CONCLUSIONS: RM&G partnerships vary according to local circumstances. It is likely that groupings will develop in the future with increasing co-terminosity and across wider health organization boundaries, such as Strategic Heath Authorities (in the UK) or primary care research networks. Critical mass of RM&G arrangements is likely to be linked to levels of research activity. There are real concerns over the levels of bureaucracy associated with the implementation of research governance; however, those PCOs that develop as RM&G sites have the opportunity to enrich their organizations and expand clinically relevant R&D. Partnership working within PCOs and with primary care research networks, academic departments or acute trusts, may be the key to success. Those undertaking research within primary care settings outside of the UK can learn important lessons from the UK experience and ensure development of high quality research that informs improvements in patient care.

Delivery of Health Care↗

PubMed1998

Polycystic ovary syndrome: anomalies in progesterone production.

The underlying cause of anovulation and miscarriage in polycystic ovary syndrome (PCOS) is unknown. Progesterone may play an important role in oocyte fertilization and embryo implantation. Therefore, in this study we analyse the endocrine function of luteinizing granulosa cells to synthesize progesterone in vivo and in vitro in PCOS and normal patients participating in an in-vitro fertilization programme. Human luteinizing granulosa cells were obtained from 10 patients with normal ovaries (controls) and 10 patients with PCOS by follicular aspiration of individual follicles of each patient and pooled in an attempt to obtain three groups: cells from follicle sizes < or =10,>10< or =15 and > or =16. Serum concentrations of oestradiol and progesterone on the day of human chorionic gonadotrophin (HCG) injection were significantly higher (P < 0.01 and P < 0.05) in PCOS patients than in controls. After HCG stimulation, in-vitro progesterone production was enhanced in granulosa cells of the control group and concentrations increased with follicular size as expected. However, the concentration of progesterone of PCOS patients did not increase with follicular size and there was a significant difference between normal and PCOS groups in follicles >10< or =15 mm (P < 0.05) and > or =16 mm (P < 0.01). Oestradiol production was increased in follicles > or =16 mm in both groups, although this did not reach significance. In summary, it seems that PCOS granulosa cells demonstrate an abnormal capacity to synthesize progesterone in vivo and in vitro. The understanding of granulosa cell function in PCOS may explain the anovulation and miscarriage that occurs in these patients.

Abortion, Spontaneous↗

PubMed1999

Recombinant human follicle stimulating hormone versus human menopausal gonadotrophin induction: effects in mature follicle endocrinology.

To investigate follicular effects of recombinant human follicle stimulating hormone (rhFSH) induction on women with polycystic ovary syndrome (PCOS), steroid content was compared in mature follicles obtained using a long luteinizing hormone-releasing hormone agonist plus rhFSH or human menopausal gonadotrophin (HMG) in PCOS women and controls participating in an in-vitro fertilization programme. Follicular fluids (144 samples) were collected at oocyte retrieval by individual selective aspiration. Oocyte maturity and fecundability were assessed. Plasma and intrafollicular 17beta-oestradiol, progesterone, testosterone concentrations were assayed individually. No significant difference was seen in oocyte maturity and fecundability between PCOS and controls following rhFSH, or between PCOS rhFSH and HMG group. 17beta-oestradiol, testosterone and progesterone concentrations were lower in PCOS follicular fluid following rhFSH than HMG but the difference was not significant. Progesterone concentration, 17beta-oestradiol/progesterone, 17beta-oestradiol/testosterone were significantly different between the two induction groups, for PCOS fertilized oocyte follicles (P = 0.01, P < 0.05 and P < 0.05 respectively). Steroidogenic enzymatic activity seems to be regulated in healthy follicular cells in PCOS as well as in normal patients upon ovarian induction. Following rhFSH, higher PCOS follicular progesterone concentrations leading to a theoretically increased fecundability could suggest that recombinant FSH is a better inducer which needs to be confirmed.

Adult↗

PubMed2003

Insulin resistance in patients with polycystic ovary syndrome is associated with elevated plasma homocysteine.

BACKGROUND: Elevated levels of plasma homocysteine have recently been implicated as a significant risk factor for cardiovascular disease, pre-eclampsia, and recurrent pregnancy loss, and have been found to be associated with insulin resistance in a number of clinical situations. We examined the relationship between plasma homocysteine and insulin resistance in patients with polycystic ovary syndrome (PCOS). METHODS: A total of 155 infertile patients with PCOS as defined by clinical, biochemical and ultrasound criteria were screened for insulin resistance utilizing single-sample fasting insulin and glucose measurement, calculated by glucose:insulin ratio or homeostasis model assessment (HOMA) index. Total plasma homocysteine was measured by fluorescence polarization immunoassay. One hundred normo-ovulatory women with normal ovaries being treated for other infertility diagnoses served as a control group. RESULTS: Insulin resistance was found in the majority of PCOS patients: -53.5% (83/155), 60.6% (94/155) and 65.8% (102/155), when defined by fasting insulin, glucose:insulin ratio, or logHOMA respectively. Mean plasma homocysteine in the PCOS group was significantly higher than in the normal ovary group (11.5 +/- 7.4 versus 7.4 +/- 2.1 micromol/l, P < 0.001). Insulin-resistant PCOS patients had significantly higher plasma homocysteine (12.4 +/- 8.4 micromol/l) than non-insulin-resistant PCOS patients (9.6 +/- 4.4 micromol/l) regardless of body mass index (P = 0.003 by groups, P = 0.005 by correlation of single samples). Thirty-four per cent (53/155) of the PCO patients had homocysteine values >95th percentile of the controls (11.0 micromol/l, P < 0.0001). Statistically significant correlations were found between all insulin resistance indices and homocysteine levels. Multiple logistic regression defined insulin resistance as the major factor examined that influenced homocysteine levels. CONCLUSIONS: Insulin resistance and hyperinsulinaemia in patients with PCOS is associated with elevated plasma homocysteine, regardless of body weight. This finding may have important implications in the short term regarding reproductive performance, and in the long term regarding cardiovascular complications associated with insulin-resistant PCOS.

Body Weight↗

PubMed2004

Growth hormone secretion is impaired but not related to insulin sensitivity in non-obese patients with polycystic ovary syndrome.

BACKGROUND: The aim of the study was to elucidate the relationship between growth hormone (GH) secretion and insulin resistance in polycystic ovary syndrome (PCOS) patients. In order to exclude the influence of obesity on these parameters, only non-obese PCOS patients were studied. METHODS: Eleven PCOS patients and 11 controls with a body mass index (BMI) </= 25 kg/m2 were studied. PCOS patients were studied on cycle day 14-15, controls on cycle day 5-9. GH secretion was determined by frequent sampling, from 20.00 h to 08.00 h. Insulin sensitivity was determined by a euglycaemic hyperinsulinaemic clamp and was expressed as the M-value. Insulin-like growth factor-1 (IGF-1) and IGF-binding protein-3 (IGFBP-3) levels were determined once. RESULTS: Pooled GH levels were significantly lower in PCOS patients than controls, as was GH pulse amplitude. The number of GH pulses was not different between PCOS patients and controls. The M-value was significantly lower in PCOS patients, although a wide overlap between patients and controls was present. IGF-1 and IGFBP-3 levels were not different between the groups. There was no correlation between the M-value and pooled GH or IGF-1 and IGFBP-3 levels. CONCLUSION: Non-obese patients with PCOS have impaired GH secretion and some but not all have impaired insulin sensitivity. These findings indicate that these patients may also be at risk for cardiovascular diseases and/or diabetes mellitus.

Area Under Curve↗

PubMed2004

Height, weight, and motor-social development during the first 18 months of life in 126 infants born to 109 mothers with polycystic ovary syndrome who conceived on and continued metformin through pregnancy.

BACKGROUND: We prospectively assessed growth and motor-social development during the first 18 months of life in 126 live births (122 pregnancies) to 109 women with polycystic ovary syndrome (PCOS) who conceived on and continued metformin (1.5-2.55 g/day) through pregnancy. METHODS: The lengths and weights of PCOS neonates were compared with gender-specific Centers for Disease Control and Prevention (CDC) infant data. Gestational diabetes (GD) and pre-eclampsia in women with PCOS were compared with 252 healthy women without PCOS who had >or=1 live birth (262 live births). RESULTS: There were 101 out of 126 (80%) term (>or=37 gestational weeks) PCOS births, which was not significantly different (P = 0.7) from controls, 206 out of 252 (81.7%). There were two (1.6%) birth defects. GD occurred in nine out of 119 PCOS pregnancies (7.6%) versus 40 out of 251 (15.9%) controls, P = 0.027. The prevalence of pre-eclampsia did not differ in PCOS versus control pregnancies (4.1 versus 3.6%, P = 0.8). The birth length and weight of the 52 male neonates did not differ (P > 0.05) from those of CDC males; the 74 female neonates were shorter than CDC females (48.9 +/- 5.4 versus 50.6 +/- 2.7 cm, P = 0.006) and weighed less (3.09 +/- 0.85 versus 3.29 +/- 0.52 kg, P = 0.04). There were no systematic differences in growth between PCOS and CDC infants over 18 months. At 3, 6, 9, 12 and 18 months, of a potential 100% motor-social development score, scores (+/-SD) were 95 +/- 13, 98 +/- 8%, 95 +/- 10, 97 +/- 8 and 94 +/- 16%; no infants had motor-social developmental delays. CONCLUSIONS: Metformin reduced development of GD, was not teratogenic and did not adversely affect birth length and weight, growth or motor-social development in the first 18 months of life.

Adult↗

PubMed2004

Surrogate end-points or primary outcomes in clinical trials in women with polycystic ovary syndrome?

There are multiple surrogate variables in polycystic ovary syndrome (PCOS), including biometric and biochemical parameters. The number of surrogate variables and their poor validity in relationship to primary clinical end-points pose major problems to conducting a trial in women with PCOS. The aim of this review is to discuss the use of surrogate variables compared with primary clinical end-points in women with PCOS. Arguably the best documented correlation between a surrogate variable and a primary clinical end-point is that between ovulation and pregnancy in women with PCOS. Good correlation has been noted between the increase in ovulation frequency with clomiphene citrate and the chance of pregnancy in women with PCOS. However, ovulation cannot be equated with pregnancy, as a host of other factors may affect the true outcome of interest: a healthy liveborn child. Pregnancy and an improvement in hirsutism are clinical end-points that have been successfully studied in past and ongoing clinical trials in women with PCOS. Many other clinical end-points, such as endometrial cancer and cardiovascular disease, are rare in premenopausal women with PCOS, and may not be suitable as the primary outcome of clinical studies. Future multicentre trials in women with PCOS should focus on primary clinical end-points.

Female↗

PubMed2004

Patterns of hormonal response to the GnRH agonist leuprolide in brothers of women with polycystic ovary syndrome: a pilot study.

BACKGROUND: The aim of this study was to evaluate the effect of a single dose of leuprolide acetate on gonadotrophin and gonadal steroid secretion in brothers of women with polycystic ovary syndrome (PCOS), in order to assess P450c17alpha activity. An oral glucose tolerance test (OGTT) and a lipid profile were also performed. METHODS: Twenty-two unrelated brothers of women with PCOS (PCOS(b)) and 14 brothers of normal cycling women (C(b)), matched for age, underwent a leuprolide acetate test (10 microg/kg s.c.) and an OGTT with measurement of circulating concentrations of gonadotrophins, steroid hormones, glucose, insulin and lipids. RESULTS: Clinical and basal hormonal parameters were similar in both groups. After leuprolide administration, PCOS(b) exhibited a significant increase of 17alpha-hydroxyprogesterone (17-OHP) compared to C(b) (P<0.05). However, only 45% of PCOS(b) showed a supranormal increase of 17-OHP (2 SD above the respective control group mean values, P<0.003) with a normal gonadotrophin response (group 1). The other 55% of the PCOS(b) exhibited a normal 17-OHP response to the analogue (group 2). However, in group 2, basal steroid concentrations did not show a uniform pattern: six of the PCOS(b) exhibited high basal androstenedione (2 SD above the respective control group mean values), three were very similar to C(b), and the other three presented lower basal testosterone concentrations (2 SD below the respective control group mean values) than those observed in C(b). CONCLUSIONS: This study shows that different responses to leuprolide in PCOS brothers make evident the heterogeneity of this syndrome in which P450c17alpha activity could be involved.

17-alpha-Hydroxyprogesterone↗