A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women

Overview

This study is designed as on observational, retrospective, and prospective clinical registry aimed at collecting comprehensive real-world data on women in perimenopause, menopause, and with premature ovarian insufficiency (POI) attending a specialized Menopause Clinic and a Multidisciplinary Outpatient Clinic dedicated to Endocrinology and Metabolic Disorders. The registry comprises both retrospective data, extracted from the medical records of eligible patients evaluated from January 2000 onward, and prospective data, which will be continuously collected for all newly referred patients up to 2040. This combined design allows the longitudinal observation of clinical characteristics, management strategies, and health outcomes across different stages of the menopausal transition and premature ovarian insufficiency within routine clinical practice. Clinical management and therapeutic strategies, including hormone replacement therapy and non-hormonal interventions, will be documented. Laboratory data, as well as imaging data routinely used in clinical practice, will be recorded when available. Enrolled patients will undergo a personalized follow-up schedule based on clinical findings and the conclusions of each visit, in accordance with standard clinical practice. Follow-up visits may be scheduled annually for routine monitoring or at shorter intervals (semi-annual or quarterly) in the presence of conditions requiring closer clinical surveillance. The registry is intended to reflect real-world clinical practice and to support the descriptive evaluation of patterns of care, symptom burden, and longitudinal clinical outcomes in women undergoing the menopausal transition or affected by premature ovarian insufficiency. The collected data will provide a structured platform for epidemiological analyses and hypothesis-generating observational research aimed at improving the understanding and management of menopausal health and associated endocrine and metabolic conditions.

This study is designed as on observational, retrospective, and prospective clinical registry aimed at collecting comprehensive real-world data on women in perimenopause, menopause, and with premature ovarian insufficiency (POI) attending a specialized Menopause Clinic and a Multidisciplinary Outpatient Clinic dedicated to Endocrinology and Metabolic Disorders. Only visits performed within these dedicated ci outpatient settings will be included in the registry. The registry comprises both retrospective data, extracted from the medical records of eligible patients evaluated from January 2000 onward, and prospective data, which will be continuously collected for all newly referred patients up to 2040. This combined design allows the longitudinal observation of clinical characteristics, management strategies, and health outcomes across different stages of the menopausal transition and premature ovarian insufficiency within routine clinical practice. Data collected within the registry include demographic characteristics, general and gynecological medical history, reproductive history, lifestyle factors, and comorbidities. Menopause-related symptoms reported by the patients will be systematically recorded, and validated questionnaires may be administered when clinically indicated to provide an objective assessment of symptom severity and impact on quality of lite, including Female Sexual Function lndex (FSFI), Visual Analogue Scale (VAS), Vaginal Health lndex (VHI), and the Day to Day lmpact of Vaginal Aging (DIVA). Clinical management and therapeutic strategies, including hormone replacement therapy and non-hormonal interventions, will be documented. Laboratory data, encompassing hormonal, metabolic, and biochemical parameters, as well as imaging data routinely used in clinical practice, will be recorded when available. lmaging assessments include dual-energy X-ray absorptiometry (DEXA) for bone health evaluation, transthoracic echocardiography and carotid Doppler ultrasound tor cardiovascular risk assessment, and transvaginal pelvic ultrasound for gynecological evaluation. Enrolled patients will undergo a personalized follow-up schedule based on clinical findings and the conclusions of each visit, in accordance with standard clinical practice. Follow-up visits may be scheduled annually for routine monitoring or at shorter intervals (semi-annual or quarterly) in the presence of conditions requiring closer clinical surveillance. The registry is intended to reflect real-world clinical practice and to support the descriptive evaluation of patterns of care, symptom burden, and longitudinal clinical outcomes in women undergoing the menopausal transition or affected by premature ovarian insufficiency. The collected data will provide a structured platform for epidemiological analyses and hypothesis-generating observational research aimed at improving the understanding and management of menopausal health and associated endocrine and metabolic conditions.