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There is a growing need for new antibiotics. Compounds that target the proton motive force (PMF), uncouplers, represent one possible class of compounds that might be developed because they are already used to treat parasitic infections, and there is interest in their use for the treatment of other diseases, such as diabetes. Here, we tested a series of compounds, most with known antiinfective activity, for uncoupler activity. Many cationic amphiphiles tested positive, and some targeted isoprenoid biosynthesis or affected lipid bilayer structure. As an example, we found that clomiphene, a recently discovered undecaprenyl diphosphate synthase inhibitor active against Staphylococcus aureus, is an uncoupler. Using in silico screening, we then found that the anti-glioblastoma multiforme drug lead vacquinol is an inhibitor of Mycobacterium tuberculosis tuberculosinyl adenosine synthase, as well as being an uncoupler. Because vacquinol is also an inhibitor of M. tuberculosis cell growth, we used similarity searches based on the vacquinol structure, finding analogs with potent (∼0.5-2 μg/mL) activity against M. tuberculosis and S. aureus. Our results give a logical explanation of the observation that most new tuberculosis drug leads discovered by phenotypic screens and genome sequencing are highly lipophilic (logP ∼5.7) bases with membrane targets because such species are expected to partition into hydrophobic membranes, inhibiting membrane proteins, in addition to collapsing the PMF. This multiple targeting is expected to be of importance in overcoming the development of drug resistance because targeting membrane physical properties is expected to be less susceptible to the development of resistance.
Induction of ovulation by adding DEX (high dose, short course) to CC in CC-resistant PCOS with normal DHEAS is associated with no adverse anti-estrogenic effect on the endometrium and higher ovulation and pregnancy rates in a significant number of patients. Induction with DEX appears to be independent on age, period of infertility, BMI or WHR.
This study investigated the presence of carbohydrates N-acetyl-d-glucosamine and sialic acid oligosaccharides, in the uterine epithelium of pseudopregnant rats treated with ovarian hormones and Clomiphene citrate (CC) a commonly used fertility drug associated with low pregnancy rates. Ovariectomized sexually mature rats were given 0.25mg CC prior to the implantation-priming hormone sequence of 5mg progesterone for 3 days and a single dose of 0.5microg estradiol-17beta (E(2)) on day 3 (PP(PE)) and sacrificed 24h after the last hormone treatment. Uterine tissue was incubated with the lectin Triticum vulgare (wheat germ agglutinin, WGA), associated with avidin and subsequently labelled with biotinylated-ferritin for electron microscopy, a combined alcian blue/PAS technique for light microscopy and RT-PCR was run for progesterone-associated endometrial protein (PAEP) gene, a pregnancy related endometrial gene that is associated with the protein thought to express carbohydrates in the uterus and suppress immune function. The results indicate that CC administration decreases the expression of these carbohydrates both at a cellular level and genetic level when compared to the PP(PE) group. However, the lowest expression of N-acetyl-d-glucosamine and sialic acid was seen in the placebo group. The ovarian hormones were therefore shown to be important for the synthesis of these carbohydrates that are important in the implantation period and the maintenance of pregnancy. The results suggest that the effect of CC on the expression of N-acetyl-d-glucosamine and sialic acid is a significant reason why there are low pregnancy rates with CC use.
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Patients were stratified according to basal FSH and E2: FSH<10 mIU/mL and E2<40 pg/mL (group 1A), FSH<10 mIU/mL and E2≥40 pg/mL (group 1B), FSH, 10-15 mIU/mL and E2<40 pg/mL (group 2A), and FSH, 10-15 mIU/mL and E2≥40 pg/mL (group 2B).
Prospective Randomised trial.
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This was a retrospective, cohort study performed in an academic reproductive endocrine practice. PCOS patients presenting for first-trimester ultrasound were identified and assigned to 1 of 3 groups: CC-resistant patients who conceived after use of metformin +/- CC (group A), CC-resistant patients who conceived after gonadotropins (group B) and PCOS patients who conceived with CC only (group C). Multiple pregnancy outcome data were collected by chart review and patient interview.
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One hundred and seventy-nine infants fulfilled the screening criteria during this period. Acute ROP was detected in 32.4% (58 infants) and stage 3 ROP developed in 15.6% (28 infants). Twenty-one infants (11.7%) were born after assisted conception, with 12 (6.7%) being conceived by IVF. The others were conceived on clomiphene (8) or after intrauterine insemination (1). Assisted conception accounted for 21.4% of all those reaching stage 3 disease and 28.6% of those infants requiring treatment. Of the 12 infants conceived by IVF, 41.6% (5 infants) developed acute ROP which progressed to threshold ROP in all infants (100%). Of the assisted conception babies requiring treatment for ROP, 83.3% were conceived by IVF. The other child had been conceived on clomiphene. The gestational age and birth weight of the IVF infants reaching stage 3 ROP were 26.6 +/- 0.89 weeks and 937 +/- 170.2 g. The gestational age and birth weight in the rest of the infants reaching stage 3 ROP were lower than in those conceived by assisted conception (25.739 +/- 1.13 weeks and 735.29 +/- 117.70 g); however, this did not approach statistical significance (p = 0.35 and p = 0.13, respectively).
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Ovary artery blood flow impedance, dimensions, and vascularization of the dominant follicle and of the CL.
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Physiologically, the epithelium of the mouse vagina undergoes conversion during early postnatal life from columnar to stratified squamous. A similar process in the human occurs in the late first and early second trimesters of pregnancy. The mouse vagina has been identified as a good developmental model of the human. Previous work in the mouse has shown that this process is affected by neonatal administration of diethylstilbestrol. We have administered diethylstilbestrol and clomiphene citrate to parallel groups of BALB/c neonatal mice. They were followed up to 24 weeks. In both groups, persistent columnar or heterotopic columnar epithelium, not seen in the control mice, was identified and associated with adenosis. This effect of diethylstilbestrol and clomiphene citrate appears to be similar to the biologic response to transplacental diethylstilbestrol in the human. After transplacental diethylstilbestrol, malignant vaginal tumors rarely develop. If clomiphene citrate, given to the human prior to pregnancy to induce ovulation or by inadvertence during pregnancy, were to circulate into the critical time of vaginal differentiation, a similar biologic potential may exist. The first situation seems to be unlikely. The second is of more concern.
Two review authors independently selected trials, extracted the data and assessed trial quality. Studies were pooled where appropriate using a fixed effect model to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs) for most outcomes and risk differences (RDs) for ovarian hyperstimulation syndrome (OHSS). The primary outcomes were live birth and OHSS. Secondary outcomes were pregnancy, miscarriage and multiple pregnancy. The quality of the evidence for each comparison was assessed using GRADE methods.
Experiment 1: Tubal epithelial organ explant cultures were established from nine women undergoing hysterectomy. Several segments from each tube were fixed immediately (in vivo control), the remainder were maintained in culture for one week. One group received no hormontal treatment (in vitro control). The others were supplemented with E2 2 ng/ml (low E2) or 10 ng/ml (high E2), Clomiphene citrate 300 ng/ml + low E2 (CC), and progesterone 300 ng/ml + low E2 (P4). All specimens were examined by scanning electron microscopy and the percent ciliated area determined. Experiment 2: Tubal epithelial cultures were established from an additional 11 patients. After 1 week in culture, half of the explants from each patient were supplemented with E2 15 ng/ml vs no E2 and maintained for another week. The specimens were examined as above, as well as with transmission electron microscopy (TEM).
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To show the success of intracytoplasmic sperm injection (ICSI) in cases of a low number of oocytes retrieved.
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A total of 72 pregnancies was achieved in 59 women with menstrual cycle disturbances (WHO Type II) by administration of clomiphene. 27 of these pregnancies (34.7%) occurred only after more than three courses of cloimphene. A secondary classification of the patients was based on the symptomatic severity of the menstrual disturbance. Clomiphene (100 mg) was administered on the fifth day after the onset of menstruation for five days, whereby in one or two cases up to 19 courses had to be given. The group consisted of women who had rejected HMG-HCG therapy because of the possibility of multiple pregnancy. 59 pregnancies went to full term; 2 tubal pregnancies and 11 cases of miscarriage were recorded. The commencement of pregnancy was evaluated and the time of ovulation and the length of the luteal phase determined in women requiring up to three courses of clomiphene and those requiring over three courses. The investigation demonstrates that clomiphene therapy can be successful even after more than six courses of the drug. Side effects are minimal.
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An electronic literature search was performed using MEDLINE, EMBASE, SCOPUS, CENTRAL, Cochrane, and U.S. Food and Drug Administration databases, restricted to studies conducted on humans and published in English.
Studies on mild, minimal and natural IVF cycles have yielded promising results, but have focused on fresh embryo transfers and included relatively young patient populations who generally have the potential for more favourable outcomes. The efficacy of these protocols in patients with a poorer prognosis remains to be tested. When comparing protocols for COS, it is important to think beyond current primary endpoints, and to consider the ideal quality and quantity of oocytes and embryos being produced per stimulated patient, in order to achieve a pregnancy. We should also focus on the cumulative pregnancy rate, which is based on outcomes from fresh and frozen embryos from the same cycle of stimulation. Individualised COS (iCOS) determined by the use of biomarkers to test ovarian reserve has the potential to optimise outcomes and reduce safety issues by adapting treatment protocols according to each patient's specific characteristics. As new objective endocrine, paracrine, functional and/or genetic biomarkers of response are developed, iCOS can be refined further still, and this will be a significant step towards a personalised approach for IVF.
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In the roundtable that follows, clinicians discuss a study published in this issue of the Journal in light of its methodology, relevance to practice, and implications for future research. Article discussed: Hurst BS, Hickman JM, Matthews ML, Usadi RS, Marshburn PB. Novel clomiphene "stair-step" protocol reduces time to ovulation in women with polycystic ovarian syndrome. Am J Obstet Gynecol 2009;200:510.e1-510.e4.
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Aging has an impact on male fertility potential, as well as potential genetic effects for the offspring.
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Any effect of IVF relative to expectant management, clomiphene citrate, IUI with or without ovarian stimulation and GIFT in terms of live-birth rates for couples with unexplained subfertility remains unknown. The studies included are limited by their small sample size so that even large differences might be hidden. Live-birth rates are seldom reported. Periods of follow up are inadequate and unequal. Adverse effects such as multiple pregnancies and ovarian hyperstimulation syndrome have also not been reported in most studies. Larger trials with adequate power are warranted to establish the effectiveness of IVF in these women. Future trials should not only report rates per woman/couple but also include adverse effects and costs of the treatments as outcomes. Factors that have a major effect on these outcomes such as fertility treatment, female partner's age, duration of infertility and previous pregnancy history should also be considered.
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Previous reports have indicated an association between endometrial development and pregnancy outcome for patients treated with clomiphene citrate (CC) in conjunction with intrauterine insemination or intercourse. We expanded the use of CC for ovulation induction in association with in vitro fertilization (IVF). This study was designed to determine if endometrial thickness should be used as an inclusion or exclusion criterion for CC-IVF.
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Prospective follow-up study.
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Cytogenetic analysis of oocytes for aneuploidy, premature centromere separation, premature anaphase, and single chromatids, and the frequencies of metaphase I and diploid oocytes.
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The use of ovulation induction combined with intrauterine insemination (IUI) as a treatment for subfertility in women with patent Fallopian tubes has increased in recent years. Little is known regarding the efficacy of this treatment in women aged >/=40 years. We reviewed our data in our ovulation induction with IUI programme for 168 consecutive patients aged >/=40 years undergoing a total of 469 cycles of treatment. Either sequential clomiphene citrate and human menopausal gonadotrophins or daily gonadotrophins were utilized along with timed IUI insemination. In 402 completed cycles, 28 clinical pregnancies occurred. The pregnancy loss rate was 34.4%. The overall ongoing/viable pregnancy rates per initiated and completed cycles were 4.47 and 5.22% respectively. No viable pregnancies occurred in 136 cycles in women aged >/=43 years. The ongoing/variable cycle fecundity rates for women aged 40, 41, and 42 years were 9.6, 5.2, and 2.4% per cycle respectively. When utilized in women aged >=40 years, ovulation induction with IUI is most likely to result in successful pregnancy in women 40-42 years of age. Women >/=43 years should consider other alternatives such as adoption or egg donation.
The levels of immunoreactive cholesterol, total cholesterol, high-density lipoprotein-cholesterol, very-low-density lipoprotein-cholesterol were determined in follicular lipoprotein-cholesterol were determined in follicular fluid samples obtained during transabdominal-transvesicular aspiration of follicles under ultrasound guidance, from patients treated with clomiphene citrate and human menopausal gonadotropin for in vitro fertilization. Insulin was measured by radioimmunoassay and cholesterol by an enzymatic method.
To compare the effectiveness of an electrocautery strategy with ovulation induction using recombinant follicle stimulating hormone in patients with polycystic ovary syndrome.
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Management of male infertility is always a difficult task. In recent years booming of artificial reproductive technologies (ART) has put infertologists and andrologists in front of a million dollar question whether to treat the person or the gametes. A basic andrology laboratory at present has become part and parcel of an infertility clinic. Hence treatment of male infertility has become institutional and collective for clinicians and basic scientists. The basic approach towards management of male infertility includes confirmation of diagnosis and to find out the cause for which pathological, endocrinological and biochemical tests are essential. In this series specific defects causing seminopathy has been found in 18% cases where treatment is straightforward and towards the cause. The main bulk of idiopathic seminal defects (82%) really poses challenge to the infertologists so far management is concerned. In this study commonest seminal defect has been found to be oligoasthenozoospermia which amounts to 63% cases. For medical management purpose drugs commonly used are clomiphene, gonadotrophins, bromocriptine, L-thyroxine, vitamin E, B12, etc. When they fail the main approach remains to be intra-uterine insemination (IUI) and ART eg, in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI).
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The age of patients, duration of infertility, and body mass index in both groups were similar. There was statistically significant difference in the thickness of the endometrium in favor of the group having the letrozole-metformin therapy (8.9 ± 1.7 mm) compared with the group receiving the clomiphene citrate-metformin treatment (6.3 ± 1.3 mm). The number of follicles was not statistically significantly different. Pregnancy rate in the first cycle of IUI in the clomiphene citrate group was 6.4%, and 17.2% in the letrozole group, which also was not statistically different. After the third IUI cycle, the pregnancy rate was significantly higher in the letrozole group (20.6%), while in the clomiphene citrate group it was (9.6%).
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Validation cohort of 108 treatment-naïve anovulatory PCOS patients.
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Placenta protein 14 (PP14), which is the most abundant product of the secretory endometrium, has been proposed as the best biochemical marker of endometrial function in women. In this study, 19 normogonadotrophic women of infertile couples were monitored with serial measurements of concentrations of PP14, gonadotrophins and sex steroids and ultrasound scanning of endometrial thickness throughout three consecutive cycles. The first two of these were natural, unstimulated cycles (cycles 1 and 2), while ovarian stimulation with clomiphene and human menopausal gonadotrophin combined with assisted reproduction (intrauterine insemination in four cases and in-vitro fertilization in 15) was performed in the third cycle (cycle 3). A newly developed enzyme-linked immunosorbent assay was used to measure serum PP14 concentrations. In cycle 3, seven women became pregnant (group A) and 12 did not (group B). Circulating concentrations of PP14 were significantly lower in group A than in group B throughout all three cycles and in all cycle phases with exception of the late luteal phase of cycle 3, during which PP14 concentrations in group A were significantly higher than in group B. Statistical analyses showed no significant correlations between serum concentrations of PP14 and follicle stimulating hormone, luteinizing hormone and progesterone, and endometrial thickness. By contrast, serum oestradiol concentrations during the pre-ovulatory phase were significantly correlated with PP14 concentrations during the mid-luteal phase of the cycle. It is concluded that circulating PP14 is a most reliable biochemical marker of endometrial function in women and that relatively low concentrations in serum during the natural, unstimulated cycle are significantly correlated to implantation and pregnancy during successive assisted reproduction cycles. Measurement of PP14 in serum may thus be useful as a method of screening endometrial function in women, before commencing troublesome and costly treatment for infertility. However, further studies in a much larger number of women are needed to confirm this observation and to elucidate the as yet undefined physiological functions of PP14 in women.
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Polycystic ovary syndrome (PCOS) is a complex lifelong disorder with an etiology and pathophysiology that is not yet entirely understood. Women with PCOS have clinical presentations that may vary from adolescence to menopause, including menstrual irregularity/anovulation and symptoms of hyperandrogenism, such as acne and hirsutism. Over a lifetime, treatment needs and requirements can change. Unfortunately, there are no Food and Drug Administration-approved medications that are approved solely for the purpose of PCOS, but the symptoms and presentation of PCOS are often amenable to several approved agents, such as oral contraceptives for the indication of acne and clomiphene citrate for the indication of induction of ovulation. However, to meet the needs of women with PCOS, off-label use of medications has flourished. This review explores the data for those agents that do not carry an indication for PCOS but have been used for treating the signs and symptoms of PCOS.