Pharmacoeconomy in ART: The importance of the gonadotrophin choice

Abstract Assisted Reproductive Technologies (ART) have created a number of relevant economic implications. Results deriving from cost-effectiveness studies have had some important medical and social consequences. The costs of ART are specific to the healthcare system in each of the countries were the procedure is performed, reflecting the varying degrees of public and private responsibility for purchasing healthcare and total healthcare expenditure. The analysis of different cost components per treatment cycle demonstrates that the hormonal stimulation stage is the most expensive part of IVF/ICSI cycles. The use of a more costly preparation could be justified only in case of a significantly higher live birth rate. Currently, human gonadotrophins seem to be more cost-effective than recombinant preparations

Effect of prenatal exposure to maternal cortisol and psychological distress on infant development in Bengaluru, southern India: a prospective cohort study.

BACKGROUND: The mental health status of a pregnant woman and its consequent impact on foetal well being is not given much importance compared to the risk imposed by obstetric complications and medical conditions. Maternal psychological distress is a major public health problem and needs timely detection and intervention to prevent any adverse pregnancy outcome. There is ample evidence from literature that justifies the association of prenatal maternal mental stress and elevated cortisol with delayed infant motor and cognitive development; evidence from India being rather limited. The study aim is to prospectively assess the association of maternal psychological distress and cortisol level with motor and cognitive development of the infant. METHODS: A sample of 2612 eligible pregnant women who have been registered for antenatal care at selected public sector hospitals in Bengaluru will be recruited after obtaining written informed consent. They will be assessed for the presence of maternal psychological distress in the form of depression and anxiety using appropriate scales and saliva samples will be collected for cortisol estimation during early, mid and late pregnancy. Follow up visits after delivery will be done on day 10, 3 months, 8 months and 12 months. The Bayley Scales of Infant and Toddler Development [BSID] (Third edition) will be used to measure both motor and mental milestones in terms of Psychomotor Development Index (PDI) and Mental Development Index (MDI). Logistic regression model will be used to determine the association between the exposure variables and outcomes which will be reported as Odd's Ratio (OR) and 95% confidence intervals (CI). DISCUSSION: Our study findings could add to the growing evidence that maternal psychological distress during pregnancy adversely influences growth and development in the offspring and subsequent development of the child. While maternal anxiety and depression can be measured by using self reporting instruments, estimation of maternal endogenous cortisol levels could serve as a biomarker of prenatal psychological stress. Findings from this study could be used to focus upon the burden of mental health problems during pregnancy and to consider steps to scale up prenatal mental health services in health care settings

Fertility after "only B-Lynch" suture: A case report and literature review

Abstract Objective A new fertility assessment after a B-Lynch suture without a concomitant uterine devascularization is proposed. Case Report The case of a 37-year-old woman who experienced postpartum hemorrhage due to uterine atony during cesarean delivery of the previous pregnancy is reported. A B-Lynch brace suturing technique, not associated to any other hemostatic surgical procedure, was carried out. One year later and after an uncomplicated pregnancy of 39 weeks, the patient delivered a healthy infant by an elective cesarean section. Only omental adhesions were found on the anterior surface of the uterus as a consequence of the previous B-Lynch suture. Conclusion The B-Lynch hemostatic surgical procedure, alone, does not seem to have a negative impact on fertility. Additional clinical evidences in a greater case-series of patients are needed to assess the value of the method for fertility preservation

Endovascular management of massive post-partum haemorrhage in abnormal placental implantation deliveries

Objectives: To retrospectively evaluate safety and efficacy of pelvic artery embolisation (PAE) in post-partum haemorrhage (PPH) in abnormal placental implantation (API) deliveries. Methods: From January 2009 to November 2013, 12 patients with API and intractable intraoperative PPH underwent PAE after caesarean delivery to control a haemorrhage (in four of these cases after hysterectomy). Arterial access was obtained prior to the delivery; PAE was performed in the obstetrics operating room by an interventional radiologist that was present with an interventional radiology (IR) team during the delivery. Results: PAE was successful in preventing bleeding and avoid hysterectomy in four cases (group A). Uterine atony and disseminated intravascular coagulation caused failure of PAE requiring hysterectomy in four patients (group B). PAE prevented bleeding post-hysterectomy in the remaining four cases (group C). Technical success (cessation of contrast extravasation on angiography or occlusion of the selected artery) was 100 %. Maternal and foetal mortality and morbidity were 0 %. Conclusions: PAE is a minimal invasive technique that may help to prevent hysterectomy and control PPH in API pregnancies without complications. Embolisation should be performed on an emergency basis. For such cases, an IR team on standby in the obstetrics theatre may be useful to prevent hysterectomy, blood loss and limit morbidity. Key Points: • Endovascular treatment is a validated technique in post-partum haemorrhage. • Abnormal placental implantation is a risk factor for post-partum haemorrhage. • We propose an interventional radiologist standby in the delivery room. © 2015, European Society of Radiology

Clinical Evaluation of a Custom Gene Panel as a Tool for Precision Male Infertility Diagnosis by Next-Generation Sequencing

Background: Up to 15% of couples are infertile and male factor infertility accounts for approximately 50% of these cases. Male infertility is a multifactorial pathological condition. The genetic of male infertility is very complex and at least 2000 genes are involved in its etiology. Genetic testing by next-generation sequencing (NGS) technologies can be relevant for its diagnostic value in male infertile patients. Therefore, the aim of this study was to implement the diagnostic offer with the use of an NGS panel for the identification of genetic variants. Methods: We developed an NGS gene panel that we used in 22 male infertile patients. The panel consisted of 110 genes exploring the genetic causes of male infertility; namely spermatogenesis failure due to single-gene mutations, central hypogonadism, androgen insensitivity syndrome, congenital hypopituitarism, and primary ciliary dyskinesia. Results: NGS and a subsequent sequencing of the positive pathogenic or likely pathogenic variants, 5 patients (23%) were found to have a molecular defect. In particular, pathogenic variants were identified in TEX11, CCDC39, CHD7, and NR5A1 genes. Moreover, 14 variants of unknown significance and 7 novel variants were found that require further functional studies and family segregation. Conclusion: This extended NGS-based diagnostic approach may represent a useful tool for the diagnosis of male infertility. The development of a custom-made gene panel by NGS seems capable of reducing the proportion of male idiopathic infertility

Impact of Probiotic SYNBIO Administered by Vaginal Suppositories in Promoting Vaginal Health of Apparently Healthy Women

The purpose of this study was to investigate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether it promotes normalization and maintenance of pH and Nugent score. A single-arm, open-label controlled towards the baseline (pre–post) study including 35 apparently healthy women was conducted. Each woman was examined three times during the study. Women were instructed to receive daily for 7 days, the probiotic suppositories SYNBIO® gin (Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®). Vaginal swabs were collected during visit 1, 2, and 3 to determine the total lactobacilli count, the presence of the two administered bacteria, the measure of the pH, and the estimation of Nugent score. Evaluation of treatment tolerability was based on analysis of the type and occurrence of adverse events. The probiotic vaginal suppository was well tolerated and no side effects were reported. Intermediate Nugent score was registered in 40 % of women at visit 1 and these intermediate scores reverted to normal at day 7 (end of treatment) in 20 % of subjects. Administration of SYNBIO® gin contributed to a significant increase in the lactobacilli level at visit 2. Molecular typing revealed the presence of the two strains originating from SYNBIO® gin in 100 % of women at visit 2 and 34 % at visit 3. No significant changes were registered for pH between visits. The SYNBIO® gin product is safe for daily use in healthy women and it could be useful to restore and maintain a normal vaginal microbiota

The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care#

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detection and scavenging of hydroxyl radical via d phenylalanine hydroxylation in human fluids

Abstract Hydroxyl radical (.OH) is highly reactive, and therefore very short-lived. Finding new means to accurately detect .OH, and testing the ability of known .OH scavengers to neutralize them in human biological fluids would leverage our ability to more effectively counter oxidative (.OH) stress-mediated damage in human diseases. To achieve this, we pursued the evaluation of secondary products resulting from .OH attack, using a detection system based on Fenton reaction-mediated D -phenylalanine ( D -Phe) hydroxylation. This reaction in turn generates o-tyrosine (o-tyr), m-tyrosine (m-tyr) and p-tyrosine (p-tyr). Here, these isomers were separated by HPLC, equipped with fluorescence detectors due to the natural fluorescence of these hydrotyrosines. By extension, we found that, adding radical scavengers competed with D -Phe on .OH attack, thus allowing to determine the .OH quenching capacity of a given compound expressed as inhibition ratio percent (IR%). Using a kinetic approach, we then tested the .OH scavenging capacity (OHSC) of well-known antioxidant molecules. In a test tube, N,N′-dimethylthiourea (DMTU) was the most efficient scavenger as compared to Trolox and N-Acethyl- L -cysteine, with NAC being the less effective. OHSC assay was then applied to biological fluid samples as seminal plasma, human serum from normal subjects and patients undergoing hemodialysis (HD), colostrum and human breast milk from mothers that received daily doses of 30 g of chocolate (70% cocoa) during pregnancy. We found that a daily administration of dark chocolate during pregnancy almost doubled OHSC levels in breast milk (1.88 ± 0.12 times, p D -Phe hydroxylation is a suitable method for routine and non-invasive evaluation of .OH detection and its scavenging in human biological fluids

Clinical and Economic Impact of Adopting Noninvasive Prenatal Testing as a Primary Screening Method for Fetal Aneuploidies in the General Pregnancy Population.

peer reviewed[en] OBJECTIVE: To evaluate the clinical and economic impact of adopting noninvasive prenatal testing (NIPT) using circulating cell-free DNA as a first-line screening method for trisomy 21, 18, and 13 in the general pregnancy population. METHODS: A decision-analytical model was developed to assess the impact of adopting NIPT as a primary screening test compared to conventional screening methods. The model takes the Belgium perspective and includes only the direct medical cost of screening, diagnosis, and procedure-related complications. NIPT costs are EUR 260. Clinical outcomes and the cost per trisomy detected were assessed. Sensitivity analysis measured the impact of NIPT false-positive rate (FPR) on modelled results. RESULTS: The cost per trisomy detected was EUR 63,016 for conventional screening versus EUR 66,633 for NIPT, with a difference of EUR 3,617. NIPT reduced unnecessary invasive tests by 94.8%, decreased procedure-related miscarriages by 90.8%, and increased trisomies detected by 29.1%. Increasing the FPR of NIPT (from < 0.01 to 1.0%) increased the average number of invasive procedures required to diagnose a trisomy from 2.2 to 4.5, respectively. CONCLUSION: NIPT first-line screening at a reasonable cost is cost-effective and provides better clinical outcomes. However, modelled results are dependent on the adoption of an NIPT with a low FPR

Evaluation of quantitative fFn test in predicting the risk of preterm birth

To evaluate diagnostic accuracy of quantitative fetal fibronectin (qfFN) test in predicting preterm birth (PTB) risk &lt;34 weeks' gestation or within 14 days from testing. We explored the predictive potential of the test in five-predefined PTB risk categories based on predefined qfFN thresholds (&lt;10, 10-49, 50-199, 200-499 and ≥500 ng/mL)