Developing a core outcome set for future infertility research : An international consensus development study

STUDY QUESTION: Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form

Role of Macroautophagy in Mammalian Male Reproductive Physiology

Physiologically, autophagy is an evolutionarily conserved and self-degradative process in cells. Autophagy carries out normal physiological roles throughout mammalian life. Accumulating evidence shows autophagy as a mechanism for cellular growth, development, differentiation, survival, and homeostasis. In male reproductive systems, normal spermatogenesis and steroidogenesis need a balance between degradation and energy supply to preserve cellular metabolic homeostasis. The main process of autophagy includes the formation and maturation of the phagophore, autophagosome, and autolysosome. Autophagy is controlled by a group of autophagy-related genes that form the core machinery of autophagy. Three types of autophagy mechanisms have been discovered in mammalian cells: macroautophagy, microautophagy, and chaperone-mediated autophagy. Autophagy is classified as non-selective or selective. Non-selective macroautophagy randomly engulfs the cytoplasmic components in autophagosomes that are degraded by lysosomal enzymes. While selective macroautophagy precisely identifies and degrades a specific element, current findings have shown the novel functional roles of autophagy in male reproduction. It has been recognized that dysfunction in the autophagy process can be associated with male infertility. Overall, this review provides an overview of the cellular and molecular basics of autophagy and summarizes the latest findings on the key role of autophagy in mammalian male reproductive physiology

The effect of aromatase inhibitors on infertile men and its relation to sexual desire

Background: Aromatase inhibitors (AI) can boost endogenous testosterone production without increasing circulating estrogen levels, as shown with estrogen receptor modulators, Aim and Objectives: The study's goal was to determine the efficacy of aromatase inhibitor medication in improving spermatogenesis in oligozoospemic and azoospermic males, as well as its relationship to sexuality. Subjects and methods: This study was done on eighty man subjects joining the outpatient clinic of Andrology, Kasr El Aini Hospital, Cairo University during the peroid from April 2018 – April 2020, and they were divided into (2) groups, 40 subjects in each group.  Results: There was a statistically significant difference in serum total testosterone measured before and after treatment in normal FSH patients with a p value ≤ 0.05. There was a notably not important change in sexual desire questionnaire measured before and after treatment in normal FSH patients with a p value > 0.05, Conclusion: ERs and aromatase share topographic sites in the brain with pheromones, indicating that estrogen influences both early sexual maturation and sexual behavior in adults. Estrogen can maintain libido while also influencing the number of serotonin receptors in the brain, which modulates mood, mental state, cognition, and emotion

The effect of aromatase inhibitors on infertile men and its relation to sexual desire

Background: Aromatase inhibitors (AI) can boost endogenous testosterone production without increasing circulating estrogen levels, as shown with estrogen receptor modulators, Aim and Objectives: The study's goal was to determine the efficacy of aromatase inhibitor medication in improving spermatogenesis in oligozoospemic and azoospermic males, as well as its relationship to sexuality. Subjects and methods: This study was done on eighty man subjects joining the outpatient clinic of Andrology, Kasr El Aini Hospital, Cairo University during the peroid from April 2018 – April 2020, and they were divided into (2) groups, 40 subjects in each group.  Results: There was a statistically significant difference in serum total testosterone measured before and after treatment in normal FSH patients with a p value ≤ 0.05. There was a notably not important change in sexual desire questionnaire measured before and after treatment in normal FSH patients with a p value > 0.05, Conclusion: ERs and aromatase share topographic sites in the brain with pheromones, indicating that estrogen influences both early sexual maturation and sexual behavior in adults. Estrogen can maintain libido while also influencing the number of serotonin receptors in the brain, which modulates mood, mental state, cognition, and emotion

The Effect of Aromatase Inhibitors on Infertile Men and Its Relation to Sexual Desire

Background: Aromatase inhibitors (AI) can boost endogenous testosterone production without increasing circulating estrogen levels, as shown with estrogen receptor modulators, Aim and Objectives: The study's goal was to determine the efficacy of aromatase inhibitor medication in improving spermatogenesis in oligozoospemic and azoospermic males, as well as its relationship to sexuality. Subjects and methods: This study was done on eighty man subjects joining the outpatient clinic of Andrology, Kasr El Aini Hospital, Cairo University during the peroid from April 2018 – April 2020, and they were divided into (2) groups, 40 subjects in each group. Results: There was a statistically significant difference in serum total testosterone measured before and after treatment in normal FSH patients with a p value ≤ 0.05. There was a notably not important change in sexual desire questionnaire measured before and after treatment in normal FSH patients with a p value > 0.05, Conclusion: ERs and aromatase share topographic sites in the brain with pheromones, indicating that estrogen influences both early sexual maturation and sexual behavior in adults. Estrogen can maintain libido while also influencing the number of serotonin receptors in the brain, which modulates mood, mental state, cognition, and emotion