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OBJECTIVES: The aim of this study was to evaluate the impact of pre- mature progesterone rise on the day of human chorionic gonadotropin (hCG) administration on the outcome of in vitro fertilization (IVF) of frozen embryo transfer (FET) cycles using cleavage-stage embryos. METHODS: This was a retrospective, cohort study of 131 ovarian stimulation cycles followed by cleavage-stage frozen embryo transfers. The first group consisted of women undergoing FET due to premature luteinization during controlled ovarian stimulation (n = 56, P ≥1.2 ng/ml). The controls were represented by women undergoing FET not complicated by high progesterone levels at induction (n = 75, P < 1.2 ng/ml). For both groups, the progesterone was measured on the day of hCG administration and the fertilization rate, cleavage rate, implantation rate, clinical pregnancy rate, ongoing pregnancy rate and Top-Quality Embryos (TQE) rates were compared. RESULTS: The increase of progesterone in patients of the Group A had no significant effects on the number of oocytes retrieved or available for the insemination. The fertilization rate, cleavage rate and implantation rates, as well as the clinical pregnancy rate and ongoing pregnancy were very similar in both study groups. The analysis of TQE rates between the two groups indicated a roughly comparable result. CONCLUSIONS: The results of this study showed that progesterone elevation on the day of hCG administration did not affect the outcomes of IVF with frozen embryos at cleavage stage. This study therefore confirms that for patients with high progesterone levels the right way to obtain a healthy pregnancy should be to delay the embryo transfer at a successive FET cycle, not associated with the ovarian stimulation.

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STUDY QUESTION: Can traceability of gametes and embryos be ensured during IVF? SUMMARY ANSWER: The use of a simple and comprehensive traceability system that includes the most susceptible phases during the IVF process minimizes the risk of mismatches. WHAT IS KNOWN ALREADY: Mismatches in IVF are very rare but unfortunately possible with dramatic consequences for both patients and health care professionals. Traceability is thus a fundamental aspect of the treatment. A clear process of patient and cell identification involving witnessing protocols has to be in place in every unit. To identify potential failures in the traceability process and to develop strategies to mitigate the risk of mismatches, previously failure mode and effects analysis (FMEA) has been used effectively. The FMEA approach is however a subjective analysis, strictly related to specific protocols and thus the results are not always widely applicable. To reduce subjectivity and to obtain a widespread comprehensive protocol of traceability, a multicentre centrally coordinated FMEA was performed. STUDY DESIGN, SIZE, DURATION: Seven representative Italian centres (three public and four private) were selected. The study had a duration of 21 months (from April 2015 to December 2016) and was centrally coordinated by a team of experts: a risk analysis specialist, an expert embryologist and a specialist in human factor. Principal investigators of each centre were first instructed about proactive risk assessment and FMEA methodology. A multidisciplinary team to perform the FMEA analysis was then formed in each centre. After mapping the traceability process, each team identified the possible causes of mistakes in their protocol. A risk priority number (RPN) for each identified potential failure mode was calculated. The results of the FMEA analyses were centrally investigated and consistent corrective measures suggested. The teams performed new FMEA analyses after the recommended implementations. PARTICIPANTS/MATERIALS, SETTING, METHODS: In each centre, this study involved: the laboratory director, the Quality Control & Quality Assurance responsible, Embryologist(s), Gynaecologist(s), Nurse(s) and Administration. The FMEA analyses were performed according to the Joint Commission International. MAIN RESULTS AND THE ROLE OF CHANCE: The FMEA teams identified seven main process phases: oocyte collection, sperm collection, gamete processing, insemination, embryo culture, embryo transfer and gamete/embryo cryopreservation. A mean of 19.3 (SD ± 5.8) associated process steps and 41.9 (SD ± 12.4) possible failure modes were recognized per centre. A RPN ≥15 was calculated in a mean of 6.4 steps (range 2-12, SD ± 3.60). A total of 293 failure modes were centrally analysed 45 of which were considered at medium/high risk. After consistent corrective measures implementation and re-evaluation, a significant reduction in the RPNs in all centres (RPN <15 for all steps) was observed. A simple and comprehensive traceability system was designed as the result of the seven FMEA analyses. LIMITATIONS, REASONS FOR CAUTION: The validity of FMEA is in general questionable due to the subjectivity of the judgments. The design of this study has however minimized this risk by introducing external experts for the analysis of the FMEA results. Specific situations such as sperm/oocyte donation, import/export and pre-implantation genetic testing were not taken into consideration. Finally, this study is only limited to the analysis of failure modes that may lead to mismatches, other possible procedural mistakes are not accounted for. WIDER IMPLICATIONS OF THE FINDINGS: Every single IVF centre should have a clear and reliable protocol for identification of patients and traceability of cells during manipulation. The results of this study can support IVF groups in better recognizing critical steps in their protocols, understanding identification and witnessing process, and in turn enhancing safety by introducing validated corrective measures. STUDY FUNDING/COMPETING INTEREST(S): This study was designed by the Italian Society of Embryology Reproduction and Research (SIERR) and funded by the Italian National Transplant Centre (CNT) of the Italian National Institute of Health (ISS). The authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: N/A.

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Se estudiaron 50 familias a las que se realizó un seguimiento durante 14 años y de las cuales uno de los padres fue diagnosticado como psicótico por los servicios psiquiátricos de adultos. Se estudiaron también 117 niños prematuros con elevadísimo riesgo neuropsíquico que fueron seguidos conjuntamente con sus familias durante 15 años y 51 padres tuvieron un seguimiento desde el séptimo mes después de la concepción hasta los 6 años de vida del niño. Se presentan algunos aspectos de la evolución y necesidades en el desarrollo de la función parental en los diferentes momentos de vida de los padres y de los niños, más de 30 tipos diferentes de intervenciones, así como los abordajes terapéuticos (AU)

This paper presents a 14 years longitudinal study of 50 families with a psychotic parent diagnosed by an adult psychiatric service. 117 preterm children with very high neuropsychological risk together with their families where also followed for 15 years, and 51 parents where followed from the 7th month of conception up to the sixth year of life. The paper reviews some aspects of the development and needs of the parental function throughout different moments of the life of parents and children, and points out at least 30 different types of interventions and therapeutic approaches (AU)

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AIM: Intracytoplasmic sperm injection (ICSI) is employed routinely in the assisted reproductive technique, in particular in case of male factor infertility. Recently, some options have been introduced in the micromanipulation system employed in ICSI, improving the performance of this technique. One of these is a no-contact laser, mostly used for the assisted hatching and the blastomere biopsy in preimplantation genetic diagnosis. One of the most important step of the ICSI technique is the sperm immobilization. Normally, this is performed by the operator and needs some time. METHODS: A one-year perspective-comparative study has been carried out and the results obtained with the traditional technique of immobilization of spermatozoa have been compared with those obtained with the laser technique (spermatozoa previously immobilized by no-contact laser). We have evaluated 3 parameters: 1) fertilization rate; 2) cleavage rate and 3) time needed to immobilize sperm. RESULTS: Some interesting findings have been observed: the embryo quality, fertilization rate and cleavage rate seem the same in both groups. The most interesting finding is the drastic reduction of the time needed for microinjection when the laser technique is used. CONCLUSIONS: This technique will reduce the total time needed to perform the ICSI, decreasing the time of exposure of the gametes outside the incubator and reducing the possibility of irreversible damage.

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OBJECTIVE: The purpose of the present study was to determine the accuracy of Osteometer diagnostic test to estimate the rate of postmenopausal bone loss (% per year) by means of combined evaluation of mineralometric and biochemical data of bone turnover. STUDY DESIGN: This was a one-year analytic study of 58 post-menopausal, apparently health, women whose last spontaneous menstrual period was at least 12 months before study entry. Bone mineral content in the forearm and biochemical indicators of calcium metabolism in urine and serum were periodically assessed. MAIN OUTCOME MEASURES: Bone Mineral Content (BMC), plasmatic estradiol, FSH, LH, Fasting Urine Hydroxyproline/Creatinine (FU Hpr/Cr), Fasting Urine Calcium/Creatinine (FU Ca/Cr), serum bone Gla protein (sBGP), serum Alkaline Phosphatase (sAP) were measured in all subjects. RESULTS: One year after the first evaluation (BMC measurement and biochemical markers of bone turnover evaluation), percent changes of bone mineral content was compared to estimation of annual bone loss by Osteometer diagnostic test. The data show that at first evaluation it was predicted an annual bone loss of 1.2 +/- 0.3%. Periodically monitored after 1 year the same patients reported a mean decrease of 0.8 +/- 0.1% of bone mineral content. If so, no statistically differences were found between data predicted and data evaluated at control one year after. DISCUSSION: The use of Osteometer Diagnostic test, using BMC measurements of forearm and biochemical parameters, represents a safe and simply method to detect post-menopausal women and its permits to identify fast bone mass looser among post-menopausal women.

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Effects of frequency and dose variation of GnRH administration by minipumps Zyklomat, were studied in five women during luteal phase. As controls were assumed the same patients; in fact they had been previously treated with pulsatile GnRH with constant dose and frequency all over the cycle. Then the patients received the same treatment but the dose and the frequency of infusion were changed in the luteal phase. Our data show an increase of mean levels of progesterone and oestradiol during the luteal phase and a better pregnancy rate when the frequency and the dose of GnRh administration were changed.

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Flare-Up study and gonadotropin-oestradiol extinction pattern were examined in two groups of 11 and 10 patients during treatment with Triptorelin LA. Plasmatic gonadotropin and oestradiol levels were evaluated by LIA and RIA respectively. The resulting data confirm that LH levels show an increase sixfold than basic values (Flare-Up effect), while FSH levels increase twice after two days of treatment. This effect was exhausted in five days. Gonadotropin-oestradiol extinction pattern demonstrates a condition of hypogonadotropic hypogonadism after two weeks of treatment with LHRHa. This study could explain some aspects of a LHRH-a action, namely for their clinical use in ovulation induction protocols.

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The suppression of the positive oestradiol (E2) feed-back mechanism was studied in 21 patients during treatment with long acting GnRHa-triptorelin 3.75 mg (Ipsen-Biotech). A basal sample for FSH, LH and E2 evaluation was taken before a single administration of 2.5 mg of oestradiol benzoate (EB) i.m. at 24 and 48 hours later. The test was performed 1, 2, 3, 4, 5, 6 and 7 weeks after i.m. injection of GnRHa. The E2 concentration 24 hours after EB injection was > 400 pg/ml, able to induce, in physiological conditions, a positive feedback. In the other hand no FSH an LH rise was observed in all test after 1, 2, 3, 4, 5, 6 and 7 weeks from GnRHa administration. Our results show the absolute suppression of the positive feed-back mechanism during the treatment with a single dose of long acting tryptorelin 3.75 mg i.m., the same results were obtained until the 7th week after GnRHa administration.

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The use of GnRH pulsatile to induce ovulation is an efficacious and safe form of therapy in hypogonadotropic hypogonadism, whereas greater difficulties are encountered in the treatment of chronic anovulation due to PCOD. The paper reports the results of 12 ovulation induction cycles using a GnRH micropump without and after GnRH analogues.

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Mortality and long-term outcome in low birthweight infants (less than or equal to 1500 g) treated in the neonatal intensive care unit of the Department of Pediatrics of the University of Padua in 1975, 1978/79, and 1983 were analysed. Mortality rates fell from 75% in 1975 to 58% in 1978/79 and to 33% in 1983. Incidence of sequelae decreased from 1975 to 1978/79 and did not change between 1978/79 and 1983. No perinatal pathology (RDS, hyperbilirubinemia, endocranial hemorrhage) was statistically related with long-term outcome, but some associations (RDS + endocranial hemorrhage + seizures) appeared more frequently in cases which presented major neurological sequelae.

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In a follow-up study of 144 newborns at high neuropsychic risk the parents were interviewed during the hospital stay and the infants were followed up one week after discharge and at 3, 6, 9 and 12 months of corrected age. The protocol included pediatric examination, neuromotor assessment, caring observation and assessment on the Brunet-Lézine developmental scale at 16 and 12 months of corrected age. An attempt was made to correlate the parents' personality structure, present experience and capacity for attunement with the infant to his development and wellbeing. After the exclusion of 11 infants with severe neuropsychic sequelae, the sample was made up of 133 infants. It was found that: despite prolonged hospitalization, in some cases for over 3 months, most of the parents by the end of the hospital stay and nearly all within a month of discharge, even if their own structures were pathological or they were suffering from reactive depression, managed (sometimes with the help of the staff) to achieve attunement with their child. This enabled him to fulfil his competences, catching up quickly in performances as soon as the parents were able to understand his messages; after 6 months of corrected age blocks and regressions emerged, related to the pathological structures of the parents or to problems bearing on their own conflicts with adverse effects on the child when he started his separation-individuation process.

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The authors consider some psychodynamic aspects which may have influences Lithium Carbonate therapy in 45 patients. Transfer and contra-transfer situations are considered emphasizing how Lithium therapy with its characteristic features may promote a peculiar relationship with the therapist answering some of the needs of cyclothymic patients. The physical needs of dependence from the therapist who controls both ingestion and expulsion of Lithium can be accepted without feeling of guilt by the patient as it usually happens in cyclothymic pre-genital personalities. Lithium allows the therapist to appear as if he had great power on the patient and makes it possible for the therapist to avoid the anxiety of losing the patient at the end of the episode and to accept the pre-genital relationship as a necessity in order to continue his therapy.

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