Context:
In overweight/obese women with polycystic ovary syndrome (PCOS), the relative benefit of delaying infertility treatment to lose weight vs seeking immediate treatment is unknown.
Objective:
...We compared the results of two, multicenter, concurrent clinical trials treating infertility in women with PCOS.
Design, Setting, and Participants:
This was a secondary analysis of two randomized trials conducted at academic health centers studying women 18–40 years of age who were overweight/obese and infertile with PCOS.
Intervention:
We compared immediate treatment with clomiphene from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial (N = 187) to delayed treatment with clomiphene after preconception treatment with continuous oral contraceptives, lifestyle modification (Lifestyle: including caloric restriction, antiobesity medication, behavioral modification, and exercise) or the combination of both (combined) from the Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (OWL PCOS) trial (N = 142).
Main Outcome Measures:
Live birth, pregnancy loss, and ovulation were measured.
Results:
In PPCOS II, after four cycles of clomiphene, the cumulative per-cycle ovulation rate was 44.7% (277/619) and the cumulative live birth rate was 10.2% (19/187), nearly identical to that after oral contraceptive pretreatment in the OWL PCOS trial (ovulation 45% 67/149 and live birth: 8.5% 4/47). In comparison, deferred clomiphene treatment preceded by lifestyle and combined treatment in OWL PCOS offered a significantly better cumulative ovulation rate compared to immediate treatment with clomiphene. (Lifestyle: 62.0% 80/129; risk ratio compared to PPCOS II = 1.4; 95% confidence interval CI, 1.1–1.7; P = .003; combined: 64.3% 83/129; risk ratio compared to PPCOS II = 1.4; 95% CI, 1.2–1.8; P < .001 and a significantly better live birth rate lifestyle: 25.0% 12/48; risk ratio compared to PPCOS II = 2.5; 95% CI, 1.3–4.7; P = .01 and combined: 25.5% 12/47; risk ratio compared to PPCOS II = 2.5; 95% CI, 1.3–4.8; P = .01).
Conclusions:
These data show the benefit of improved ovulation and live birth with delayed infertility treatment with clomiphene citrate when preceded by lifestyle modification with weight loss compared with immediate treatment. Pretreatment with oral contraceptives likely has little effect on the ovulation and live birth rate compared with immediate treatment.
Comparing data from two randomized trials shows improved ovulation and live birth with delayed fertility therapy preceded by lifestyle modification compared with immediate therapy with clomiphene.
Objective To identify baseline characteristics of couples that are likely to predict conception, clinical pregnancy, and live birth after up to four cycles of ovarian stimulation with IUI in couples ...with unexplained infertility. Design Secondary analyses of data from a prospective, randomized, multicenter clinical trial investigating pregnancy, live birth, and multiple pregnancy rates after ovarian stimulation-IUI with clomiphene citrate, letrozole, or gonadotropins. Setting Outpatient clinical units. Patient(s) Nine-hundred couples with unexplained infertility who participated in the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation clinical trial. Intervention(s) As part of the clinical trial, treatment was randomized equally to one of three arms and continued for up to four cycles or until pregnancy was achieved. Main Outcome Measure(s) Conception, clinical pregnancy, and live-birth rates. Result(s) In a multivariable logistic regression analysis, after adjustment for other covariates, age, waist circumference, income level, duration of infertility, and a history of prior pregnancy loss were significantly associated with at least one pregnancy outcome. Other baseline demographic and lifestyle characteristics including smoking, alcohol use, and serum levels of antimüllerian hormone were not significantly associated with pregnancy outcomes. Conclusion(s) While age and duration of infertility were significant predictors of all pregnancy outcomes, many other baseline characteristics were not. The identification of level of income as a significant predictor of outcomes independent of race and education may reflect differences in the underlying etiologies of unexplained infertility or could reveal disparities in access to fertility and/or obstetrical care. Clinical Trial Registration NCT01044862.
Context: There is no standardized assay of testosterone in women. Liquid chromatography mass spectrometry (LC/MS) has been proposed as the preferable assay by an Endocrine Society Position Statement.
...Objective: The aim was to compare assay results from a direct RIA with two LC/MS.
Design and Setting: We conducted a blinded laboratory study including masked duplicate samples at three laboratories—two academic (University of Virginia, RIA; and Mayo Clinic, LC/MS) and one commercial (Quest, LC/MS).
Participants and Interventions: Baseline testosterone levels from 596 women with PCOS who participated in a large, multicenter, randomized controlled infertility trial performed at academic health centers in the United States were run by varying assays, and results were compared.
Main Outcome Measure: We measured assay precision and correlation and baseline Ferriman-Gallwey hirsutism scores.
Results: Median testosterone levels were highest with RIA. The correlations between the blinded samples that were run in duplicate were comparable. The correlation coefficient (CC) between LC/MS at Quest and Mayo was 0.83 95% confidence interval (CI), 0.80–0.85, between RIA and LC/MS at Mayo was 0.79 (95% CI, 0.76–0.82), and between RIA and LC/MS at Quest was 0.67 (95% CI, 0.63–0.72). Interassay variation was highest at the lower levels of total testosterone (≤50 ng/dl). The CC for Quest LC/MS was significantly different from those derived from the other assays. We found similar correlations between total testosterone levels and hirsutism score with the RIA (CC = 0.24), LC/MS at Mayo (CC = 0.15), or Quest (CC = 0.17).
Conclusions: A testosterone RIA is comparable to LC/MS assays. There is significant variability between LC/MS assays and poor precision with all assays at low testosterone levels.
There is significant variability between LC/MS assays and concerns about precision in the female normal testosterone range; results may be comparable to a well-selected radioimmunoassay.
Social reporting by islamic banks Maali, Bassam; Casson, Peter; Napier, Christopher
Abacus (Sydney),
June 2006, Letnik:
42, Številka:
2
Journal Article
Recenzirano
The last thirty years have witnessed the appearance and rapid expansion of Islamic banking both inside and outside the Islamic world. Islamic banks provide financial products that do not violate ...Sharia, the Islamic law of human conduct. The Islamic principles upon which the banks claim to operate give an important role to social issues. Applying these principles, we develop a benchmark set of social disclosures appropriate to Islamic banks. These are then compared, using a disclosure index approach, the actual social disclosures contained in the annual reports of twenty‐nine Islamic banks (located in sixteen countries) to this benchmark. In addition, content analysis is undertaken to measure the volume of social disclosures. Our analysis suggests that social reporting by Islamic banks falls significantly short of our expectations. The results of the analysis also suggest that banks required to pay the Islamic religious tax Zakah provide more social disclosures than banks not subject to Zakah.
Background While female sexual dysfunction is a frequent occurrence, characteristics in infertile women are not well delineated. Furthermore, the impact of infertility etiology on the characteristics ...in women with differing androgen levels observed in women with polycystic ovary syndrome and unexplained infertility has not been assessed. Objective The objective of the study was to determine the characteristics of sexual dysfunction in women with polycystic ovary syndrome and unexplained infertility. Study Design A secondary data analysis was performed on 2 of Eunice Kennedy Shriver National Institute of Child Health and Human Development Cooperative Reproductive Medicine Networks clinical trials: Pregnancy in Polycystic Ovary Syndrome Study II and Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation. Both protocols assessed female sexual function using the Female Sexual Function Inventory and the Female Sexual Distress Scale. Results Women with polycystic ovary syndrome had higher weight and body mass index than women with unexplained infertility (each P < .001), greater phenotypic (Ferriman-Gallwey hirsutism score, sebum score, and acne score; each P < .001), and hormonal (testosterone, free testosterone, and dehydroepiandrosterone; each P < .001) evidence of androgen excess. Sexual function scores, as assessed by the Female Sexual Function Inventory, were nearly identical. The Female Sexual Distress Scale total score was higher in women with polycystic ovary syndrome. The mean Female Sexual Function Inventory total score increased slightly as the free androgen index increased, mainly as a result of the desire subscore. This association was more pronounced in the women with unexplained infertility. Conclusion Reproductive-age women with infertility associated with polycystic ovary syndrome and unexplained infertility, despite phenotypic and biochemical differences in androgenic manifestations, do not manifest clinically significant differences in sexual function.
Objective To determine if Chlamydia trachomatis ( C. trachomatis ) seropositivity, as detected by the C. trachomatis elementary body (EB)–based enzyme-linked immunosorbent assay EB ELISA predicts ...pregnancy and pregnancy outcome among infertile women with documented tubal patency. Design Cohort study. Setting Outpatient clinics. Patient(s) In all, 1,250 infertile women with documented tubal patency enrolled in 1 of 2 randomized controlled trials: Pregnancy in Polycystic Ovary Syndrome II; and the Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation. Intervention(s) Sera were analyzed for anti– C. trachomatis immunoglobulin G (IgG)1 and IgG3 antibodies, using a research C. trachomatis EB ELISA. The optical density (OD)405 readings of ≥0.35 and ≥0.1 were considered positive for IgG1 and IgG3, respectively. Main Outcome Measure(s) Primary outcomes included pregnancy, live birth, and ectopic pregnancy. Log-linear regression was used to determine the relative risk after adjusting for age, race, treatment medication, smoking status, and current alcohol use. Result(s) A total of 243 (19%) women were seropositive for anti– C. trachomatis IgG3. They tended to be nonwhite and smokers. Anti– C. trachomatis IgG3 seropositive women were significantly less likely to conceive (risk ratio RR 0.65, 95% confidence interval CI 0.52–0.83) or to have a live birth (RR 0.59, 95% CI 0.43–0.80); these associations were weakened after adjusting for number of hysterosalpingography-documented patent tubes (RR 0.73, 95% CI 0.56–0.97) and (RR 0.73, 95% CI 0.50–1.04), respectively. Anti– C. trachomatis IgG3 seropositive women who conceived had a ×2.7 risk (95% CI 1.40–5.34) of ectopic pregnancy. Conclusion(s) Even in the presence of tubal patency, anti– C. trachomatis IgG3 seropositivity is associated with a lower likelihood of pregnancy. Anti– C. trachomatis IgG3 seropositive women have as high as 3 times the risk of ectopic pregnancy. Clinical Trial Registration Number PPCOSII: NCT00719186 and AMIGOS: NCT01044862.
Context:
Anti-Müllerian hormone (AMH) reduces aromatase activity and sensitivity of follicles to FSH stimulation. Therefore, elevated serum AMH may indicate a higher threshold for response to ...ovulation induction in women with polycystic ovary syndrome (PCOS).
Objective:
This study sought to determine the association between AMH levels and ovulatory response to treatment among the women enrolled into the Pregnancy in PCOS II (PPCOS II) trial.
Design and setting:
This was a secondary analysis of data from a randomized clinical trial in academic health centers throughout the United States
Participants:
A total of 748 women age 18–40 years, with PCOS and measured AMH levels at baseline, were included in this study.
Main Outcome Measures:
Couples were followed for up to five treatment cycles to determine ovulation (midluteal serum progesterone > 5 ng/mL) and the dose required to achieve ovulation.
Results:
A lower mean AMH and AMH per follicle was observed among women who ovulated compared with women who never achieved ovulation during the study (geometric mean AMH, 5.54 vs 7.35 ng/mL; P = .0001; geometric mean AMH per follicle, 0.14 vs 0.18; P = .01) after adjustment for age, body mass index, T, and insulin level. As AMH levels increased, the dose of ovulation induction medication needed to achieve ovulation also increased. No associations were observed between antral follicle count and ovulation.
Conclusions:
These results suggest that high serum AMH is associated with a reduced response to ovulation induction among women with PCOS. Women with higher AMH levels may require higher doses of medication to achieve ovulation.
High baseline serum AMH was associated with a reduced response to ovulation induction among women with PCOS; women with higher AMH levels may require higher doses of medication to achieve ovulation.
Objective To evaluate the impact of clomiphene citrate on vision. Design Observational study. Setting Patients were referred to the University of Ottawa Eye Institute ophthalmology clinic from the ...Department of Obstetrics and Gynaecology of the Ottawa Hospital–General Campus. Patient(s) Eight adult females taking clomiphene citrate and experiencing visual disturbances. Intervention(s) Patients received a comprehensive visual evaluation twice: once during a washout period, and once during an active clomiphene citrate treatment. Main Outcome Measure(s) Ophthalmologic examination, color vision, visual acuity, contrast sensitivity, visual fields using standard automated perimetry, and foveal flicker sensitivity at high (32 Hz) and low (8 Hz) temporal frequencies. Result(s) We found no differences between the washout and clomiphene citrate conditions for color vision, visual acuity, contrast sensitivity, and visual fields. The only statistically significant difference was found for foveal flicker sensitivity at 32 Hz in the right eye, with a similar trend in the left eye and at 8 Hz in both eyes. Conclusion(s) The effect of clomiphene citrate on vision was minimal, and the visual disturbances were reversible in all patients. A bilateral reduction in flicker sensitivity was the only observed visual disturbance. Women who experience visual symptoms associated with clomiphene citrate should be monitored, but therapy can usually be maintained.
To study whether there is a difference in the prevalence of non–cavity-distorting uterine fibroids between infertile patients with polycystic ovary syndrome (PCOS) and those with unexplained ...infertility (UI).
A secondary analysis of data from three randomized clinical trials.
Academic health centers.
A total of 2,249 patients with normal uterine cavities.
None.
The presence or absence of non–cavity-distorting fibroids.
Compared with women with UI, those with PCOS were younger, had a higher body mass index, and were more likely to be Hispanic or African American, with a lower percentage of previous conception and live birth, a higher percentage of current smokers, a lower percentage of current alcohol users, and higher total testosterone, fasting insulin, and homeostasis-model-assessment insulin resistance. The prevalence of women with non–cavity-distorting uterine fibroids was lower in women with PCOS than in those with UI (6.7% vs. 12.4%); this result held after patients were divided into Black and non-Black or into three different body mass index groups. After adjustment for all the other variables in the final model, patients with PCOS had a significantly lower prevalence of fibroids than those with UI (odds ratio 0.54). No differences in the prevalence of non–cavity-distorting fibroids with any dimensions ≥4 cm or the volume of the largest fibroid was found between the two groups.
A lower prevalence of non–cavity-distorting uterine fibroids was found in infertile women with PCOS than in those with UI.
Menor prevalencia de miomas uterinos que no distorsionan la cavidad en pacientes
con síndrome de ovario poliquístico que en aquellos con infertilidad inexplicada
Estudiar si existe una diferencia en la prevalencia de miomas uterinos que no distorsionan la cavidad entre pacientes infértiles con síndrome de ovario poliquístico (PCOS) y aquellas con infertilidad inexplicada (IU).
Un análisis secundario de los datos de tres ensayos clínicos aleatorios.
Centros académicos de salud.
Un total de 2 249 pacientes con cavidades uterinas normales.
Ninguna.
La presencia o ausencia de miomas que no distorsionan la cavidad.
En comparación con las mujeres con IU, las que tenían PCOS eran más jóvenes, tenían un índice de masa corporal más alto y era más probable que fuesen hispanas o afroamericanas, con un menor porcentaje de concepciones anteriores y nacidos vivos, un mayor porcentaje de fumadoras actuales, un menor porcentaje de usuarias actuales de alcohol, y mayor testosterona total, insulina en ayunas y en la evaluación del modelo de homeostasis de resistencia a la insulina. La prevalencia de mujeres con miomas uterinos que no distorsionan la cavidad fue menor en mujeres con PCOS que en aquellas con UI (6.7% vs. 12.4%); este hallazgo se mantuvo después de que los pacientes se dividieran entre raza negra y no negra o en tres grupos diferentes de índice de masa corporal. Después de ajustar todas las demás variables en el modelo final, las pacientes con PCOS tuvieron una prevalencia significativamente menor de miomas que aquellas con UI (odds ratio 0.54). No hay diferencias en la prevalencia de los miomas que no distorsionan la cavidad con cualquier dimensión ≥4 cm o el volumen del mioma más grande que se encontró entre los dos grupos.
Se encontró una menor prevalencia de miomas uterinos que no distorsionan la cavidad en mujeres infértiles con PCOS que en aquellas con UI.
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