A multicenter clinical study with myo-inositol and alpha-lactalbumin in Mexican and Italian PCOS patients.

OBJECTIVE: This open-label non-randomized clinical study aimed at evaluating the effects of myo-inositol plus alpha-lactalbumin in two groups of PCOS women, treated in Mexico and Italy. Alpha-lactalbumin was used being effective in increasing myo-inositol intestinal absorption. This effect is very useful in greatly reducing the therapeutic failure of myo-inositol in some patients (inositol resistant subjects). PATIENTS AND METHODS: The study involved 34 normal weight or overweight patients (14 in Mexico and 20 in Italy), aged 18 to 40 years, with anovulation and infertility > 1 year and insulin resistance diagnosed by HOMA-Index. Patients were administered orally with 2 g myo-inositol, 50 mg alpha-lactalbumin, and 200 µg of folic acid twice a day for 6 months. Controls were the same patients at t0 (baseline). The primary outcome was HOMA-index decrease after 3 and 6 months of treatment. Other parameters monitored were BMI, progesterone, LH, FSH, total testosterone, free testosterone, androstenedione, total cholesterol, HDL, LDL, triglycerides. RESULTS: Recovery was general, and its relevance was higher when the starting point was further away from the normal range. The most important results were obtained with insulin, HOMA-index, LH, and androstenedione. No significant adverse effects were detected in both groups of patients. CONCLUSIONS: This clinical trial demonstrated for the first time that myo-inositol and alpha-lactalbumin improve important parameters in PCOS patients characterized by different metabolic profiles.

Effects of micronised dispersible ferric pyrophosphate combined with alpha-lactalbumin in pregnant women affected by iron deficiency anemia: results from a prospective, double-blind, randomized controlled trial.

OBJECTIVE: This study aimed at evaluating the effects obtained by administering 30 mg of micronised dispersible ferric pyrophosphate plus 300 mg of alpha-lactalbumin (MDFP-AL) compared to 80 mg of ferrous gluconate (FG) in pregnant women affected by iron-deficiency anemia (IDA). PATIENTS AND METHODS: We considered eligible all second-trimester singleton pregnancies in women affected by IDA. We excluded any other disease, twin pregnancies, any other pharmacologic/nutraceutical treatments (besides folic acid) before/during pregnancy. We randomized patients in two groups: one underwent treatment with 1 tablet of MDFP-AL/day, the other one with 1 tablet of FG/day, for 30 days. We evaluated hemoglobin (Hb), ferritin, red blood cells (RBCs), serum iron, hematocrit (Hct), and side effects at baseline (T0), after 15 days (T1) and 30 days (T2). RESULTS: 50 women met the inclusion/exclusion criteria. We did not observe significant differences between the two groups for mean age, gestational age at the enrollment and parity. In MDFP-AL group, after 15 days (T1) Hb, ferritin, serum iron and Hct and were significantly improved respect to baseline (T0); after 30 days (T2), all the parameters, including RBCs, were significantly improved respect to baseline (T0). Similarly, in FG group the investigated parameters were improved both after 15 (T1) and 30 days (T2) respect to baseline (T0), although less in percentage terms respect to MDFP-AL group. The side effects rate was 24% in FG group, whereas MDFP-AL group did not show any significant side effect. CONCLUSIONS: Overall, MDFP-AL is more effective and safe than FG for the treatment of IDA in pregnant women.

Treatment of gestational diabetes mellitus with myo-inositol: analyzing the cutting edge starting from a peculiar case.

OBJECTIVE: The robust data about myo-inositol (Myo-Ins) safety profile and effectiveness opened a new scenario for the treatment and prevention of Gestational Diabetes Mellitus (GDM). We report our experience about a case of GDM successfully treated with Myo-Ins. PATIENTS AND METHODS: An overweight 29-year-old Caucasian pregnant woman, nulliparous, affected by GDM, according to the National Institute for Health and Care Excellence (NICE) Guideline. After diagnosis, the patient underwent regular glycemia checks: mean fasting blood glucose value was 103.63 ± 1.46 mg/dl, whereas 1-hour and 2-hours after-meal values were 122.74 ± 11.14 mg/dl and 110.74 ± 10.70 mg/dl, respectively. We decided to prescribe a low-calorie diet and oral treatment with 4 g of Myo-Ins, 3 times per day for 3 weeks. RESULTS: After the treatment, mean fasting value was 90.74 ± 5.30 mg/dl, whereas 1-hour after and 2-hours after-meal values were 108.11 ± 6.05 mg/dl and 101.21 ± 4.78 mg/dl, respectively. DISCUSSION: We reported a significant decrease of glycemia in a faster and steady way at fasting, 1-hour and 2-hours after-meal post oral treatment with 4 g of Myo-Ins 3 times per day, in a patient affected by GDM. CONCLUSIONS: On the one hand, we could confirm the safety profile of the molecule also at this high dosage, free from any side effects; on the other hand, our experience highlighted the faster glucose-lowering effect due to a higher dose of Myo-Ins. This outcome may open a new scenario in the treatment of GDM.

Beneficial effects of low doses of ethinyl-estradiol on the lipid profile in postmenopausal women.

The purpose of this study was to investigate the beneficial effects of low doses of ethinyl-estradiol on the lipid profile in postmenopausal women. One hundred and five patients (mean age [+/-S D] 42.9 +/- 5.0 years) who underwent a hysterectomy and bilateral salpingo-oophorectomy were included in the study. For the present study serum levels of total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, apolipoprotein B (apoB), and lipoprotein(a) [Lp(a)] were investigated. When all patients were considered together (Table 1), EE2 therapy significantly increased serum levels of total cholesterol, HDL cholesterol and LDL cholesterol. The ratio of HDL to LDL cholesterol, Lp(a) and triglyceride concentrations did not change significantly from the baseline value. Although our study was not randomized or controlled with a placebo, the beneficial metabolic effects of ethinyl-estradiol on lipid patterns should be considered in patients needing hormonal replacement therapy in postmenopause.

A prospective randomized study comparing intramuscular progesterone and 17alpha-hydroxyprogesterone caproate in patients undergoing in vitro fertilization-embryo transfer cycles.

OBJECTIVE: To compare the effectiveness of i.m. P and 17alpha-hydroxyprogesterone caproate (17-HPC) for luteal phase support, in patients undergoing IVF-ET cycles. DESIGN: Prospective, randomized study. SETTING: Patients undergoing IVF-ET in our Centers. PATIENT(S): The inclusion criteria were the use of GnRH down-regulation and aged <40 years. INTERVENTION(S): A total of 300 cycles were randomly treated with either 17-HPC (341 mg every 3 days) or P (50 mg daily). MAIN OUTCOME MEASURE(S): The outcomes of IVF in both study groups were evaluated for biochemical pregnancy, miscarriage, clinical pregnancy, and ongoing pregnancy. RESULT(S): No difference was found in the main outcome parameters considered. CONCLUSION(S): Although the results of the study encourage the use of 17-HPC for luteal phase support in patients undergoing IVF-ET program, more studies are necessary to support the hypothesis that it can replace i.m. P-in-oil.

Low dose of ethinyl estradiol can reverse the antiestrogenic effects of clomiphene citrate on endometrium.

Fifty healthy, voluntary patients aged between 20 and 30 years with regular menstruation and plasmatic progesterone level >10 ng/ml at the midluteal phase have been enrolled in this study. They were randomly treated with clomiphene citrate (CC; group A) or CC + ethinyl estradiol (0.05 mg group B, or 0.02 mg group C). We estimated the difference in uterine artery pulsatily index, endometrial thickness and histological dating and morphometric analysis of endometrium. No significant differences in Pulsatility Index values and in the number of preovulatory follicles were noted. The difference between endometrial thickness, histological dating and morphometric analysis of the endometrium were statistically different between groups B and C vs. A. Our study shows that CC has a deleterious effect on endometrium maturity and that adding ethinyl-E(2) produces a favorable endometrial response even with very low doses.

Use of intramuscular progesterone versus intravenous albumin for the prevention of ovarian hyperstimulation syndrome.

This study was designed to compare the effectiveness of intramuscular progesterone with that of intravenous albumin in the prevention of ovarian hyperstimulation syndrome (OHSS). Ninety-six patients at high risk to develop OHSS (estradiol concentration >9, 000 pmol/l on the day of hCG administration and over 20 follicles of a diameter larger than 14 mm observed by transvaginal ultrasonography) and undergoing in vitro fertilization-embryo transfer were enrolled. They were randomly treated with intramuscular progesterone (200 mg/day) or 100 ml of 20% intravenous albumin in order to estimate the difference in the incidence of OHSS. A significant difference in the incidence of moderate OHSS and no cases of severe OHSS were observed between the groups. Our data show the effectiveness in preventing OHSS with high doses of progesterone.

Ovarian stimulation using a new highly purified urinary FSH: a prospective randomized clinical study.

The aim of this study was to determine the effectiveness of a new highly purified urinary FSH. A total of 60 in vitro-fertilization (IVF) patients, undergoing embryo transfer (ET) for the first time, were randomly allocated into two groups: Group A (n = 30). Subcutaneous administration of urinary follicle-stimulating hormone (FSH, Fostimon 75, A.M.S.A., Italy). Group B (n = 30). Subcutaneous administration of urinary follicle-stimulating hormone (FSH, Metrodin 75 HP, Serono, Italy). Statistical analysis was performed using the chi-square test, p < 0.05 was assumed as significant. This prospective randomized clinical study in an IVF-ET program showed that both drugs were equally safe and effective. Except for the number of the high quality embryos (3.16 vs 2.9; p = 0.03) the two groups did not differ in stimulation parameters or clinical pregnancy rates per attempt and per transfer. On the other hand, a mean number of 3.56 vs 2.18 embryos were cryopreserved in group A and in group B, respectively, as a result of the high number of mature oocytes and high quality embryos. When frozen embryos cycles were included, the difference in pregnancy rate became significant.

Intramuscular versus vaginal administration of progesterone for luteal phase support after in vitro fertilization and embryo transfer. A comparative randomized study.

A total of 156 patients were randomly treated with exogenous natural progesterone (intramuscularly, 50 mg/day) and vaginal gel (90 mg/day) P or nothing (Controls) from the day before embryo transfer (ET) for two weeks. In case of positive beta-HCG, the treatment was continued for 12 weeks. Plasma P and 17 beta-Estradiol concentrations were estimated and compared with the control not supplemented group. Both treatments were able to increase significantly the luteal plasmatic values of P versus controls. The ongoing pregnancy and the living birth rates per transfer were significantly higher in the patients supplemented with intramuscular P than in those treated with vaginal gel P. The intramuscular natural P appears the most suitable route of administration for luteal phase support in IVF-ET procedures.

17-alpha-Hydroxyprogesterone caproate and natural progesterone in assisted reproduction: a comparative study.

The use of luteal phase support has been demonstrated in patients undergoing an IVF/ET procedure. This study was designed to compare the absorption and the efficacy of two different luteal supports: 17-alpha-hydroxyprogesterone caproate (Lentogest, AMSA, Italy) and natural Progesterone (Prontogest, AMSA, Italy). A total of 80 patients received luteal supplementation with 50 mg of natural P/day intramuscularly, until beta-hCG evaluation. Then, in case of positive beta-hCG, patients were randomly divided into two groups (A and B) in order to compare two different protocols: Group A, 17-OHPc (341 mg once a week) and Group B, natural P (50 mg/day) both intramuscularly and extended for 10-12 weeks. Our study showed that the treatment with 17-OHPc results in a higher percentage of pregnancy rate compared to natural P, but the differences are not statistically significant. Thus, we emphasize that 17-OHPc preparation for better acceptance appears to be the most suitable and comfortable method for luteal phase support.

Intramuscular versus vaginal progesterone in assisted reproduction: a comparative study.

The effectiveness and the absorption of two progesterone (P) presentations have been compared for luteal phase support of patients aged < or = 37 years undergoing an in vitro fertilization (IVF) procedure for the first time, who were stimulated after pituitary desensitization with gonadotrophin releasing hormone agonists (GnRHa). All of them had two ovaries, normal ovarian functions and normal endometrial morphology: the indication for the assisted reproductive technique was the tubal factor. Two hundred and fifty patients were randomly allocated to two groups in order to compare two treatment protocols: Group A: natural i.m. P (50 mg/day, Prontogest, AMSA, Italy); Group B: micronized vaginal P (200 mg/day Esolut, Angelini, Italy). We were able to show that the i.m. P resulted in a higher percentage of pregnancies than the vaginal preparation, with statistically significant differences. We recommend the use of injectable P, and suggest reserving intravaginal P as a second choice for patients who cannot tolerate intramuscular administration.

The influence of obesity in the sexual life of women in menopause. A case control study.

It seemed important to us to investigate sexuality during the post-menopausal and senile period to evaluate whether changes in sexual behaviour are related with endocrine-functional alterations brought on by menopause, or whether social-economic and environmental factors represent the principal cause. Thus 1,500 questionnaires were distributed to women aged from 50 to 87. Of the 1,500 questionnaires distributed, only 713 (47.53%) were returned completely filled-in. All women had been classified for age, civil status and life environment. Our statistic analysis does not seem to have singled out those factors that influence sexual activity in women of advanced age but shows only how age, indifferently from civil status and life environment, represents the most important factor. At the same age other factors, probably attached to psychological features and way of life and thus difficult to define and even less qualifiable, may be of influence, explaining a further percentage of control of those answers not explainable by age.

Pregnancy in adolescents. A case-control study.

OBJECTIVE: to investigate pregnancy outcome and incidence of pregnancy-related disorders in the adolescent. DESIGN: a matched control retrospective study. SUBJECTS: pregnant adolescents aged 14 to 19 years admitted to the Departments of Obstetrics and Gynecology--Policlinico Umberto I, between the years 1984 and 1993; a comparable number of pregnancies aged 20 to 24 years was considered as a control group. RESULTS: In the 10 yrs. period a total of 304 pregnancies in adolescents were considered. Preterm deliveries were 9.5% in the adolescent group vs 5.9% in control (P > 0.05). A higher incidence was found in number of cesarean section (P < 0.001), spontaneous abortion (P = 0.003), intrauterine growth retardation (P = 0.04) and fetal distress (P = 0.04) in the adolescent group vs matched controls. Also mean birth weight was significantly lower in the adolescent group when compared with normal group (P < 0.001). CONCLUSION: we found a higher incidence of obstetric complications, such as IUGR, acute fetal distress in labor and lower birth weight, in the adolescent group, resulting in a higher number of cesarean sections. We hypothesise that the relative state of "hypoarterialisation" characteristic of the adolescent uterus may be involved in the afore-mentioned complications.

An Italian survey on how information campaigns about AIDS have changed contraception in young couples. A sectional study and a comparison with the literature.

The purpose of the present investigation was to ascertain whether adolescent had been sensitized by the campaign against AIDS and if their behaviour regarding the use of contraception had changed accordingly. To this end 2,000 questionnaires (of which 1,554 were returned) were distributed to a population aged 13-20 years, recruited from high schools or sporting centers. The results of our survey, which started in 1992 and lasted 15 months, indicate that after the informative campaigns of 1986, contraceptive habits have changed, and at present, the method predominantly used by teenagers (60.6%) at their first sexual intercourse is the condom. The results of the present study have been compared with those of the literature regarding the years previous to our study. In our investigation, only 18.9% of the interviewed used oral contraception vs. 43.3% and 34.50% of those reported in 1980-85 and 1986-89, respectively. Particularly significant is the fact that 11.6% of teenagers used the condom in addition to oral contraception at their first sexual intercourse. In conclusion, we can assert that AIDS campaigns conducted in Italy, starting from 1986, has resulted in an increase of the use of condoms with respect to other methods of contraception.