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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Publication date: Available online 14 December 2018Source: Reproductive BioMedicine OnlineAuthor(s): Nasim Tabibnejad, Mohammad Hasan Sheikhha, Nasrin Ghasemi, Fesahat, Mehrdad Soleimani, Abbas AflatoonianAbstractResearch questionCan a combination of time-lapse morphokinetic parameters and cumulus cell gene expression in polycystic ovary syndrome (PCOS) women be used to predict assisted reproductive treatment outcome?DesignA total of 547 embryos from 100 intracytoplasmic sperm injection (ICSI) cycles were evaluated. Fifty women with PCOS and 50 women who were categorized as tubal factor infertility were recruited. Time-lap...
Source: Reproductive BioMedicine Online - Category: Reproduction Medicine Source Type: research
Publication date: Available online 14 December 2018Source: Reproductive BioMedicine OnlineAuthor(s): Lingjuan Wang, Su Song, Xuemei Liu, Mengdi Zhang, Wenpei XiangAbstractResearch questionIs low MFN2 expression associated with ageing in granulosa cells as well as assisted reproductive technology (ART) outcome, and what is the underlying mechanism of action of MFN2?DesignIn a prospective study, fresh granulosa cells were obtained from 161 women aged 20–40 years who underwent IVF with embryo transfer and who were divided into two groups: the diminished ovarian reserve (DOR) group (n = 51) and the control group (n...
Source: Reproductive BioMedicine Online - Category: Reproduction Medicine Source Type: research
Publication date: Available online 15 December 2018Source: Journal of Minimally Invasive GynecologyAuthor(s): Huiying Zhang, Huixia Zhang, Xueqing He, Wenyan Tian, Xueru SongABSTRACTEndometrial polyps are frequently encountered in the uterine cavity of infertile women. There is much debate regarding the treatment of endometrial polyps in patients who are undergoing assisted reproductive technology (ART). A systematic review was performed by searching PubMed, Embase, and the Cochrane Library for retrospective or prospective studies that compared the effect of hysteroscopic resection of polyps with no treatment on pregnancy ...
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
ConclusionsSelection of a single blastocyst based on information derived from time-lapse monitoring can aid embryo selection for SET.
Source: European Journal of Obstetrics and Gynecology and Reproductive Biology - Category: OBGYN Source Type: research
Endometrial polyps are frequently encountered in the uterine cavity of infertile women. There is much debate regarding the treatment of endometrial polyps in patients who are undergoing assisted reproductive technology (ART). A systematic review was performed by searching PubMed, Embase, and the Cochrane Library for retrospective or prospective studies that compared the effect of hysteroscopic resection of polyps with no treatment on pregnancy outcomes of patients who underwent ART. Primary outcomes were clinical pregnancy, live birth, miscarriage, and implantation rate after ART.
Source: The Journal of Minimally Invasive Gynecology - Category: OBGYN Authors: Tags: REVIEW ARTICLE Source Type: research
CONCLUSIONS: Women can be reassured that fertility drugs do not appear to significantly increase the risk of invasive ovarian, endometrial, breast or other cancers, while achieving a pregnancy at an earlier age is a significant protective factor. PMID: 30536354 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Polycystic ovary syndrome (PCOS) is a complex endocrine condition that represents a lifelong health concern for 1 in 10 women worldwide.1 PCOS is commonly diagnosed by the presence of ovulatory dysfunction, androgen excess, and/or ovaries with polycystic morphology on ultrasound examination.2 Half of patients experience overweight or obesity.3 Most are at increased risk for serious comorbidities, including infertility, pregnancy complications (eg, gestational diabetes mellitus), impaired glucose tolerance, insulin resistance, type 2 diabetes mellitus, cardiovascular disease, gynecological cancers, anxiety, depression, eati...
Source: Journal of the American Dietetic Association - Category: Nutrition Authors: Tags: Research Source Type: research
Abstract The existence of different bacterial communities throughout the female reproductive tract has challenged the traditional view of human fetal development as a sterile event. There is still no consensus on what physiological microbiota exists in the upper reproductive tract of the vast majority of women who are not in periods of infection or pregnancy, and the role of bacteria that colonize the upper reproductive tract in uterine diseases or pregnancy outcomes is not well established. Despite published studies and advances in uterine microbiome sequencing, some study aspects-such as study design, sampling m...
Source: Biology of Reproduction - Category: Reproduction Medicine Authors: Tags: Biol Reprod Source Type: research
ConclusionOur study showed that the microfluidic technique does not change fertilization, CPR, and LBR during IVF treatment for couples with unexplained infertility. Despite the fact that the total number of grade 1 embryos after ICSI treatment and the surplus number of grade 1 embryos after embryo transfer were higher in the microfluidic technique group, the study was not powered to detect this difference.Trial registrationNCT02488434
Source: Journal of Assisted Reproduction and Genetics - Category: Reproduction Medicine Source Type: research
It can be difficult to treat infertile patients, especially when they have very unrealistic expectations of what medicine can do for them.This is because their feelings range wildly all the way from one end of the pendulum - false hope, to the other end - false despair.False hope is the expectation that I'm going to get pregnant if I do IVF ; or that IVF has a 100% success rate .Patients who do IVF treatment with this false hope will often go to pieces when their cycle fails , because they're not able to build up the courage to try again . Because they had such high (unrealistic) expectations , they cannot deal with the fr...
Source: Dr.Malpani's Blog - Category: Reproduction Medicine Source Type: blogs
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