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A vast literature documents the role of melatonin in human reproductive function including: a) the relation between melatonin and the menstrual cycle in relation to the peak time of luteinizing hormone in the middle of the cycle; b) the varying concentrations of melatonin in the control of puberty; c) the fewer conceptions in some artic populations where melatonin is connected significantly to seasonal photoperiodicity during the months of the polar nights. The aim of this paper is to report our findings on the pharmacological action of this molecule on reproduction in which gonadal activity is clearly connected to photoperiodicity. We used polymer bioimplants programmed for the sustained release of melatonin for experimental gynecologic protocols. These implants had beneficial results with respect to the use of progestinics because melatonin allowed ovarian activity to be induced for at least two to three consecutive cycles with one single bioimplant. We thought it indispensable to use pharmacological systems with a sustained release because different preliminary tests showed that the half-life of melatonin is limited at maximum to two to three hours and, consequently, any other tested modalities of administration would not provide any appreciable results for our study. As a model for our research we used goats to administer melatonin via targeted programs since these animals clearly respond (even against the rule of the light/dark relation) in contrast to humans in whom response is less evident. For controls, after inserting bioimplants in the animals, we tested their efficiency in vitro and subsequently in vivo, evaluating blood parameters and pharmacological effects of melatonin occurring during the treatment. The final results proved to be interesting in relation to reproductive activity in that regular and programmed births were achieved.

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In this study, the pharmacologic substance reduced glutathione (GSH) was used in men with hypofertility problems linked to varicocele, in bulls with spermatozoa hypomobility due to varicocele, and in rabbits with dispermy caused by cryptorchidism. An efficacious therapeutic effect of increased motility of the spermatozoa was seen in subjects who were submitted to appropriate doses of glutathione I.M. GSH also showed some neutralizing effect on the catabolytes produced during spontaneous or induced peroxidation processes of the unsaturated lipids contained in the membranes of male germinal cells. The genetic aspects of the involved enzymes were also evaluated and the research was extended in vitro by incubating samples of spermatozoa with arachidonic acid homogenates, L-tryptophan, hematein, and with an addition of glutathione. The results showed that polynsaturated fatty acid metabolic substances (PUFA) play an important role in the acrosomal reaction of spermatozoa and that GSH has a determining role in increasing the motility of spermatozoa with consequent improved fertilization. The spermatozoa of bulls provided us with a valid model to study for the morphostructural, biochemical and pharmacological analyses of human spermatozoa.

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This study was conducted on 30 female patients (average age: 40.5 +/- 11 years, age range 19-65), affected by vulval and/or vaginal phlogosis with a prevalence of uterine fibromyomatosis and metrorrhagia of a varied nature. Sixteen patients were affected with vulvitis and 14 with vulvovaginitis. Fifteen patients were assigned to the treatment with Ibuprofen isobutanolammonium and 15 to the treatment with Benzydamine hydrochloride. Both the subjective symptoms (burning and itching) and the objective symptoms (erythema, oedema, exudation) showed a marked reduction as early as the third day of treatment and the comparison between the score at the start of treatment and on day three of the treatment was highly significant in both study groups (p < 0.01). This improvement was, however, more marked in the group of patients treated with ibuprofen isobutanolammonium, where a more rapid reduction of both the subjective and objective symptoms was observed on the third day. This trend, although not as marked as on the third day, was confirmed at the end of the study, on the seventh day.

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BACKGROUND: This study focus on the effect of 6 months transdermal estradiol therapy (TTS) on the sexual behaviour and the quality of life in early menopausal women, complaining of uncomfortable menopausal symptoms. METHODS: Three hundred and sixty-two postmenopausal women, aged 48-56, participated in this study. One hundred and seventy-one of them were given continuous solid matrix patch TTS 50 mg/day for 6 months. Sexual behaviour, menopausal symptoms and well-being were evaluated through a self-rating method. We used a structured questionnaire with three obligatory answers (less/same/more) for each question--sexual life, hot flushes, touchiness, insomnia, blood pressure, work willing, memory loss, well-being--filled in by the women themselves or by the medical equipe after a telephone interview. RESULTS: Seventy five per cent of women aged 51-53 and 84% aged 54-56, who had been treated for 6 months with TTS showed a fall of sexual drive, if compared with, respectively, 62% and 48% of untreated subjects. Relief of hot flushes, touchiness and insomnia occurred in 80% of treated women, with slight differences among the various groups while 61% showed increase of well-being. CONCLUSIONS: The results of our study demonstrate that continuous TTS for 6 months decreased sexual drive in 69% of women, improved menopausal symptoms in 80% women but increased well-being only in 61% of women. These differences suggest that women's well-being does not seem linked only to the relief of menopausal symptoms and the impairment of their sexual life can play a negative role.

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The prevention of infectious complications by antibiotic prophylaxis has made traditional or laparoscopic surgery much safer but at the same time has contributed to an uncontrolled and often irrational use of every kind of antibiotic. In this study we wanted to show that often mini-invasive surgery like laparoscopy can be practised without the use of antibiotics. Thus, postoperatively several patients undergoing laparoscopic, diagnostic and operative interventions were followed-up. The results showed that subjects without antibiotic therapy did not have any symptomatology that could be ascribed to bacterial infections. In conclusion this study has demonstrated that laparoscopic surgery, especially without any complications, should follow the elementary rules of surgical techniques and surgical asepsis and that antibiotic prophylaxis is not always necessary.

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During the past few years, experimentation in the field of assisted fertilisation has been focused on the freezing of the female gamete. This technique would allow the ethical problems relating to embryo conservation to be resolved. Unfortunately, in spite of the continuous progress made in embryology, conventional freezing methods have proved lethal to ovocytes owing to the profound morphological and functional changes that take place caused by the low temperature and the toxic action of cryoprotective agents. These alterations include: the thickening of the pellucid zone, thus preventing fertilisation; the confluence of cytoplasmatic organules into vesicles and masses; the depolymerisation of the microtubular apparatus of the meiotic spindle and loss of its orientation towards the egg cell, leading to lack of fertilisation or in the event that fertilisation takes place, a high incidence of chromosomal alterations, such as polyploidy, which are incompatible with subsequent embryonal development. This study aimed to evaluate the possibility of eliminating part of these alterations, in particular those affecting the meiotic spindle, an element of central importance in the formation of the zygote. For this purpose, ovocytes matured in vitro were treated with ionomycin, a substance capable of activating the second meiotic division, and then frozen. The mechanism of action of ionomycin can be attributed to the depolarisation of the plasmatic membrane of the ovocyte, with an increased flow of calcium ions and inhibition of a protein that blocks the second meiotic division. The activation of the second meiotic division has enabled the authors to avoid damage to the meiotic spindle resulting from freezing and to obtain encouraging results in terms of the percentage of fertilisation and embryonal development after freezing, and the subsequent insemination of the ovocyte. Embryonal development ceased during the subsequent phases for reasons that are not yet clear. However, this study showed that severe cellular damage induced by freezing is attributable to alterations to the meiotic spindle that condition the later phases of fertilisation and embryonal development.

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BACKGROUND: The aims of the current study were to investigate the value of Ca-125 maternal serum levels at the first trimester of pregnancy in order to test heir usefulness for the screening of foetal aneuploidies. MATERIALS AND METHODS: The study was performed retrospectively on frozen maternal serum samples obtained in the antenatal clinics of the department of obstetrics and gynaecology: 85 control normally cycling women, 479 pregnant over 36 years from 8th to 12th week of pregnancy underwent the villocentesis, 383 pregnant women aged from 19 to 45 years underwent the "tritest" (AFP = alpha-fetoprotein, hCG = human chorionic gonadotropin, fE3 = free estriol, age) for the screening of the Down syndrome in the second trimester of pregnancy. All newborns have been tested by Apgar score. The immunoradiometric (IRMA) Ca-125 assay was performed without knowing the result of the cytogenetic test. Over all we have had 11 patients with aneuploidy, 7 Down, 3 Edwards and 1 Patau. The levels of Ca-125 are expressed as MoM multiple of median) in order to compare the levels at different gestational age. RESULTS: We had no significant differences between normal and pathological pregnancies, therefore we don't reckon the Ca-125 assay useful in the screening of aneuploidies in the first trimester of pregnancy.

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It is generally assumed that the oral contraceptives cause the carrier proteins to change. Notoriously this effect is used to evaluate indirectly their estrogenicity/gestagenicity ratio. In order to assess the residual intrinsic androgenic activity of two new 19-nor-derivative components, Desogestrel (DG) 150 micrograms and Gestodene (GD) 75 micrograms, both in association with Ethinylestradiol (EE) 30 micrograms, Sex Hormone Binding Globulin, Thyroxine Binding Globulin, Ceruloplasmin and Free Androgen Index (FAI), were studied in 40 young normally cycling healthy volunteers, matched for body mass index and age. The participants were randomly assigned to either EE-DG or EE-GD treatment. A marked significant increase in all the carrier proteins was found. Conversely, the values for FAI decreased significantly. The changes in the two groups were substantially of the same magnitude. These results are an indirect confirmation of the well-known negligible receptor binding affinity of the two progestogen in vitro, also supporting for these compounds the lack of relevant androgenic effects.

PIP: The residual androgenic activity of two new combined oral contraceptives (OCs)--30 mcg of ethinyl estradiol in combination with either 150 mg of desogestrel or 75 mcg of gestodene--was investigated in 40 healthy volunteers. Measured in these volunteers were modifications in transport protein levels. These levels are known to be increased by estrogen, but this increase can be counterbalanced, to varying degrees, by gestagens. For both OCs, there was a marked percentage increase in sex hormone binding globulin (SHBG), corticosteroid binding globulin (CBG), thyroxine binding globulin (TBG), and ceruloplasmin (CP) and a similar reduction in total testosterone and the free androgen index. The modifications in SHBG, CBG, TBG, and CP are interpreted as an expression of the correlated value of the estrogenicity/gestagenicity ratio of the OCs studied and suggest that these particular formulations have greater estrogenicity. The relatively negligible biological androgenic activity of desogestrel and gestodene and their elevated affinity progesterone receptor/androgen receptor ratio reflect the high selectivity of these agents. Moreover, the lack of androgenic effects makes desogestrel and gestodene appropriate treatment agents for hyperandrogenism.

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The physiological importance of proteins C and S as natural anticoagulants is demonstrated by the increased risk of thromboembolic disease among subjects with hereditary deficiency of both proteins. In the present study the effects were evaluated of low-dose oestrogen oral contraceptives (OC) on the plasma levels of immunological protein S, as free (PS-f), and in reversible complex with C4b-binding protein as well as functional protein C (PC) in a homogeneous group of 20 young healthy women. The participants were randomly given either gestodene (75 micrograms) or desogestrel (150 micrograms) in combination with ethinyl oestradiol (30 micrograms). Blood samples were taken prior to the initiation of the treatment and at the end of the sixth 21-day treatment cycle. The mean concentration of both free and bound PS fell significantly, the decrease still being within the reference range. Conversely, the plasma values for PC rose to a statistically significant extent. There were no significant differences between the two OCs. Hypothetically, the changes in PS-f (active fraction) might be conducive to a procoagulant state, which the increased PC may compensate. The reverse effect of two OCs on the activity of the protein C-protein S anticoagulant system might suggest a different regulation of their synthesis.

PIP: The influence of low-dose oral contraceptives (OCs) on plasma levels of proteins C and S was investigated i 20 healthy women. These proteins, along with antithrombin III, are the most significant inhibitors of coagulation. Blood samples were collected after 6 months of treatment with an OC containing 30 mcg of ethinyl estradiol and either 150 mcg of desogestrel or 75 mcg of gestodene. A significant increase in functional protein C concentrations (from 55.70 + or - 9.84 to 117.48 + or - 21.29 in the desogestrel group and 68.80 + or - 19.11 to 135.60 + or - 28.66 in the gestodene group) was recorded between baseline and the 6-month measurement. There was a corresponding decrease in plasma concentrations of free protein S (from 98.48 + or - 9.64 to 73.96 + or - 12.07 in the desogestrel group and 104.79 + or - 31.52 to 83.14 + or - 18.28 in the gestodene group). Although these OC-induced changes were statistically significant, all values remained within the normal range. The differences between the 2 OC formulations were not significant. It is hypothesized that the changes in the active fraction of protein S recorded in OC users produce a procoagulant state and increases in protein C reflect an effort to compensate for this change. The findings that OC use increases protein C and decreases protein S values suggests that the two proteins differ in the regulation of their synthesis.

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In order to evaluate the clinical and endocrinological efficacy of two low-dose oral contraceptives (OC) containing 30 micrograms Ethinylestradiol (EE) and 150 micrograms Desogestrel (DG) and 75 micrograms Gestodene (GD), respectively, an open randomized study was carried out in 34 young hirsute women, matched for body mass index and age. All of them met endocrine and ultrasonic criteria for Micropolycystic Ovary Syndrome (MPCO). The participants were randomly assigned to one of two pill groups (each of 17). The serum values for Total Testosterone (TT), Free Testosterone (FT), Androstenedione (A), Dehydroepiandrosterone (DHEA), Dehydroepiandrosterone Sulphate (DHEAS), 17-Hydroxyprogesterone (17Pg), Sex Hormone Binding Globulin (SHBG), Ceruloplasmin (CP), as well as Ferriman-Gallwey Index (FGI) and Free Androgen Index (FAI) were evaluated prior to and after EE-DG and EE-GD 6 cycle treatment. A significant decrease in TT, FT, A, 17Pg, DHEA, DHEAS, FGI, FAI was observed, SHRG and CP increased significantly. There were no significant differences between the two OC. Our results seem to indicate that both OC are equipotent as far as their pharmacological profile and residual androgenic activity are concerned. Therefore, these OC may represent a highly effective and suitable alternative to the treatment of hyperandrogenism related to MPCO.

PIP: In order to evaluate the clinical and endocrinological efficacy of 2 low-dose oral contraceptives (OCs) containing 30 mcg ethinyl estradiol (EE) and 150 mcg desogestrel (DG) and 75 mcg gestodene (GD) respectively, an open randomized study was carried out on 34 young, hirsute women, matched for body mass index and age. All met endocrine and ultrasonic criteria for micropolycystic ovary syndrome (MPCO); participants were randomly assigned to 1 of 2 pill groups (n=17 each). The serum values for total testosterone (TT), free testosterone (FT), androstenedione (A), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulphase (DHEAS), 17-hydroxyprogesterone (17Pg), sex hormone binding globulin (SHBG), ceruloplasmin (CP), as well as Ferriman-Gallway Index (FGI), and Free Androgen Index (FAI) were evaluated prior to and after EE-DG and EE-GD 6-cycle treatment. Significant decreases in TT, FT, A, 17PG, DHEA, DHEAS, FGI, and FAI were observed; SHBG and CP increased significantly. There were no significant differences between the 2 OCs. These results seem to indicate the both OCs are equally potent in pharmacological profile and residual androgenic activity. Therefore, these OCs may represent a highly effective and suitable alternative to the treatment of hyperandrogenism related to MPCO.

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This study was designated to assess the effects of two low-dose oral contraceptives (OC) on serum lipids and lipoproteins and to compare, at same oestrogen dose (30 micrograms), the effects of desogestrel (DG) with those of a new progestin, gestodene (GD). Fifty-four young women, matched for Quetelet's Index, age, diet, alcohol consumption, smoking and exercise habits, were randomly assigned to one of two regimens. Serum high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total triglycerides (T) and cholesterol (C), apolipoprotein A-1 (Apo A) and apolipoprotein B (Apo B) were measured prior to the OC commencement and after 6-cycle treatment. Sex hormone binding globulin (SHRG) and ceruloplasmin (CP) were determined as well. LDL-C, Apo A, C, T, increased significantly from baseline values, being still the increase within the reference range. Apo B changed proportional to the LDL-C increase. A rise in HDL-C occurred but it was statistically significant in the EE-DG group only. This result would suggest that the EE-DG combination is more estrogen-dominant that the EE-GD combination. However, this hypothesis was not consistent with the increase to the similar extent for SHBG and CP, which reflect the estrogenicity/gestagenicity of the two OCs. The disproportion of change between HDL-C and Apo A in only EE-GD group might reflect some compositional change in HDL particle. There were no significant differences between the two formulations for the parameters investigated.

PIP: This study was designed to assess the effects of 2 low-dose oral contraceptives (OCs) on serum lipids and lipoproteins and to compare, at the same 30 mcg estrogen dose, the effects of desogestrel (DG) with those of a new progestin, gestodene (GD). 54 young women, matched for Quetelet's Index, age, diet, alcohol consumption, smoking, and exercise habits, were randomly assigned to 1 of 2 regimens. Serum high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL), cholesterol, total triglycerides (T), and cholesterol (C), apolipoprotein A-1 (Apo A), and Apo B were measured prior to the OC commencement and after 6 cycles of treatment. Sex hormone binding globulin (SHBG) and ceruloplasmin (CP) were determined as well. LDL-C, Apo A, C, and T increased significantly from baseline values, still remaining within the reference range. Apo B changed proportionally to the LDL-C increase. A rise in HDL-C occurred but it was statistically significant in the EE-DG group only. This result would suggest that the EE-DG combination is more estrogen dominant than the EE-GD combination; however this was not consistent with the increase to a similar extent of SHBG and CP, which reflect the estrogenicity/gestagenicity of the 2 OCs. The disproportionate change between HDL-C and Apo A in only the EE-GD group might reflect some compositional change in HDL particles. There were no significant differences between the 2 formulations for the parameters investigated.

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The antiandrogen effects of an oral contraceptive containing 0.03 mg. Ethinyl Oestradiol and 0.15 mg. Desogestrel have been evaluated in 17 non-obese hirsute women, with normal serum LH and FSH values and their ratio, and evidence for Micropolycystic Ovary Syndrome (MPCO) on ultrasound examination. At the completion of 5 cycles (21 days) of treatment, a statistically significant decrease in serum Total Testosterone, Free Testosterone, Androstenedione levels was observed. Similarly, serum values for Dehydroepiandrosterone Sulphate and 17-OH-Progesterone showed a marked fall. The Sex Hormone Binding Globulin (SHBG) values rose about four-fold, so that the Free Androgen Index was suppressed. The clinical score, evaluated according to the method of Ferriman and Gallwey, was found sharply reduced. Therefore, the well defined improvement of biochemical and clinical parameters, along with the absence of discernible side effects, are undoubtedly confirming the effectiveness of the treatment in hyperandrogenism of women with MPCO.

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This preliminary study concerns the evaluation of a chemometric technique, the so called Linear Discriminant Analysis (LDA) for an adequate nosological characterization of the more common forms of hirsutism: i.e., the Micropolycystic Ovary Syndrome (MPCO) and the Idiopathic Hirsutism (I.H.). The obtained data and, particularly, the evidence of statistically significant values of the Linear Discriminant Function (mean = 12.7; p less than 0.02), clearly show the effectiveness of LDA as a practical and suitable method for a more proper detection and classification of MPCO and I.H.

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The authors have studied the nucleolus organizing regions (NORs) from short term cultures of lymphocytes of 15 women with endometrial adenocarcinoma and 15 healthy females. In contrast with the results of Literature, the frequence of NORs in patients with endometrial adenocarcinoma does not show any significative difference.

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