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EMD Serono wins FDA nod for redesigned pen injector

Merck KGaA‘s biopharma biz, EMD Serono, said today that it won FDA approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector. The device, which was first approved in 2013, is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women. The newly-designed pen was evaluated in a simulated-use study involving 86 women with infertility and 30 fertility nurses. Get the full story at our sister site, Drug Delivery Business News. The post EMD Serono wins FDA nod for redesigned pen injector appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Wall Street Beat Women's Health emdserono Merck KGaA Source Type: news

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Authors: Palomba S, Falbo A, Daolio J, Battaglia FA, LA Sala GB Abstract Polycystic ovary syndrome (PCOS) is a common female disorder with a pathogenesis still today not completely known. To the present, PCOS is considered more than just a reproductive disorder since several metabolic consequences that could affect women's health during different stages of reproductive and post-reproductive life were reported. The aim of the current review was to evaluate present evidence-based data regarding the pregnancy complications in infertile patients with PCOS. An extensive literature search until February 2018 was performe...
Source: Minerva Ginecologica - Category: OBGYN Tags: Minerva Ginecol Source Type: research
ConclusionsThe outcomes of IVF after neosalpingostomy were matchable with salpingectomy. For patients desire to preserve fallopian tubes, we recommend laparoscopic neosalpingostomy as an alternative choice to manage moderate hydrosalpinx before IVF.
Source: Archives of Gynecology and Obstetrics - Category: OBGYN Source Type: research
ConclusionThe present review revealed a high prevalence of BV in non-pregnant women. Given that BV is associated with a series of reproductive complications such as infertility, taking preventive measures such as awareness of patients as well as monitoring and controlling of syndrome are essential.
Source: Archives of Gynecology and Obstetrics - Category: OBGYN Source Type: research
Perspectives in Psychiatric Care, EarlyView.
Source: Perspectives In Psychiatric Care - Category: Psychiatry Authors: Source Type: research
Conclusion Careful consideration of primary ectopic pregnancy data is a valuable tool to predict the potential risk of recurrence in the future.
Source: European Journal of Obstetrics and Gynecology and Reproductive Biology - Category: OBGYN Source Type: research
AbstractPurposeRatio of fetal weight to placenta size varies by mode of conception (fertility treatments utilized) in animals. Our objective was to assess whether fertility treatments also affect these ratios in humans.MethodsIn this retrospective study, we assessed two cohorts: (a) early gestation cohort, women with singleton pregnancies who underwent first trimester vaginal ultrasound and (b) delivered cohort, women who delivered a live-born, singleton infant with placenta disposition to pathology. Crown rump length (CRL) and estimated placental volume (EPV) were calculated from first trimester ultrasound images using a ...
Source: Journal of Assisted Reproduction and Genetics - Category: Reproduction Medicine Source Type: research
Publication date: June 2018 Source:Reproductive Toxicology, Volume 78 Author(s): P.A. Stapleton, C.R. McBride, J. Yi, A.B. Abukabda, T.R. Nurkiewicz Preconceptive health encompasses male and female reproductive capability. In females, this takes into account each of the stages of the estrous cycle. Microvascular reactivity varies throughout the estrous cycle in response to hormonal changes and in preparation for pregnancy. Microvascular alterations in response to engineered nanomaterial (ENM) exposure have been described within 24-h of inhalation; however, the impact upon the uterine vasculature at differing estrous stage...
Source: Reproductive Toxicology - Category: Toxicology Source Type: research
To compare sperm parameters, serum hormone levels, pregnancy and miscarriage rates between the infertile men with recurrent or persistent varicocele who underwent microsurgical subinguinal redo varicocelectomy or had observation only.
Source: Urology - Category: Urology & Nephrology Authors: Tags: Infertility Source Type: research
CONCLUSION: Our results show that Epstein-Barr infection is possibly associated with autoimmune ovarian failure. The devastating impact on fertility in such disorder can be successfully avoided by in vitro maturation of oocytes from excised ovarian tissue. PMID: 29618356 [PubMed - in process]
Source: Reproductive Biology - Category: Reproduction Medicine Authors: Tags: Reprod Biol Endocrinol Source Type: research
We examined relationships between maternal age (modeled flexibly to allow curvilinear shapes) and pregnancy outcomes using logistic regression. We plotted absolute predicted risks to display curves from age 20 to 50 estimated for two risk profiles: (1) population average values of all risk factors; (2) a low-risk profile without preexisting diabetes/hypertension, smoking, prior spontaneous/therapeutic abortion, diagnosed infertility, inadequate prenatal care, low income, rural residence, or obesity. Results: Risks of hypertensive disorders increased gradually until age 35, then accelerated. Risk of multiple gestations, ...
Source: Epidemiology - Category: Epidemiology Tags: Reproductive and Perinatal Source Type: research
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