Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study† ‡.

STUDY QUESTION: Can consensus definitions for the core outcome set for infertility be identified in order to recommend a standardized approach to reporting? SUMMARY ANSWER: Consensus definitions for individual core outcomes, contextual statements and a standardized reporting table have been developed. WHAT IS KNOWN ALREADY: Different definitions exist for individual core outcomes for infertility. This variation increases the opportunities for researchers to engage with selective outcome reporting, which undermines secondary research and compromises clinical practice guideline development. STUDY DESIGN, SIZE, DURATION: Potential definitions were identified by a systematic review of definition development initiatives and clinical practice guidelines and by reviewing Cochrane Gynaecology and Fertility Group guidelines. These definitions were discussed in a face-to-face consensus development meeting, which agreed consensus definitions. A standardized approach to reporting was also developed as part of the process. PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus development methods. MAIN RESULTS AND THE ROLE OF CHANCE: Forty-four potential definitions were inventoried across four definition development initiatives, including the Harbin Consensus Conference Workshop Group and International Committee for Monitoring Assisted Reproductive Technologies, 12 clinical practice guidelines and Cochrane Gynaecology and Fertility Group guidelines. Twenty-seven participants, from 11 countries, contributed to the consensus development meeting. Consensus definitions were successfully developed for all core outcomes. Specific recommendations were made to improve reporting. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods, which have inherent limitations. There was limited representation from low- and middle-income countries. WIDER IMPLICATIONS OF THE FINDINGS: A minimum data set should assist researchers in populating protocols, case report forms and other data collection tools. The generic reporting table should provide clear guidance to researchers and improve the reporting of their results within journal publications and conference presentations. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials statement, and over 80 specialty journals 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. Siladitya Bhattacharya 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. 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.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and a financial interest in NexHand. E.H.Y.N. reports research sponsorship from Merck. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. 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. TRIAL REGISTRATION NUMBER: Core Outcome Measures in Effectiveness Trials Initiative: 1023.

Secondary azoospermia after a successful natural pregnancy: a primary prospective study.

BACKGROUND: To date, there is a lack of studies conducted on males with secondary azoospermia as a potential cause of male infertility who had previously fathered children through natural conception. The current study aims to investigate the potential causes of secondary azoospermia as a presentation of male infertility as well as the prognostic factors that can impact sperm retrieval rate (SRR) while undergoing microdissection testicular sperm extraction (microTESE). RESULTS: Thirty two patients were recruited from the andrology outpatient clinic from August 2023 till January 2024. The mean age of the patients was sixty-two years old. All patients had varicoceles. Twenty seven patients (84%) had palpable varicocele grade 2 and 3 on both sides. Further multivariate logistic regression analysis of the significant factors in the univariate regression revealed that younger age (OR 0.7, 95% C.I. 0.7-1.0, p = 0.03) and having a history of coronary artery disease (CAD) were predictable factors for negative TESE outcome (OR 123.1, 95% C.I. 3.2-4748.5, P = 0.01). CONCLUSION: It appears that the etiopathogenesis of secondary azoospermia are multifactorial. Varicocele and CAD are major factors to be considered. Future studies should be implemented deploying larger pools of patients suffering from the same condition to affirm the findings of this primary study.

RéSUMé: CONTEXTE: À ce jour, il existe un manque d'études menées chez des hommes atteints d'azoospermie secondaire comme cause potentielle d'infertilité masculine, alors qu'ils avaient déjà engendré des enfants par conception naturelle. La présente étude vise à étudier les causes potentielles de l'azoospermie secondaire en tant que présentation de l'infertilité masculine, ainsi que les facteurs pronostiques qui peuvent avoir un impact sur le taux de récupération des spermatozoïdes (SRR) lors de l'extraction de spermatozoïdes testiculaires par microdissection (microTESE). RéSULTATS: Trente-deux patients ont été recrutés dans la clinique ambulatoire d'Andrologie d'août 2023 à janvier 2024. L'âge moyen des patients était de soixante-deux ans. Une varicocèle était présente chez tous les patients. Vingt-sept patients (84%) présentaient une varicocèle palpable de grade 2 et trois une varicocèle bilatérale. Une analyse par régression logistique multivariée des facteurs significatifs lors de la régression univariée a révélé qu'avoir un âge plus jeune (OR 0,7, IC à 95 % 0,7-1,0, p = 0,03) et des antécédents de maladie coronarienne (coronaropathie) étaient des facteurs prédictifs d'un résultat négatif à la microTESE (RC 123,1,95 % IC 3,2-4748,5, p = 0,01). CONCLUSIONS: Il apparaît que l'étiopathogénie de l'azoospermie secondaire est multifactorielle. La varicocèle et la coronaropathie sont des facteurs majeurs à prendre en compte. De futures études devraient être mises en œuvre en déployant des groupes de patients plus nombreux présentant la même affection pour confirmer les résultats de cette étude primaire.