{"id":301,"title":"Reproductive Outcome Registration in Phase 3 Weight-Management Pharmacotherapy Trials: A Cross-Sectional Meta-Research Study","title_zh":"3期减重药物临床试验中生殖结局指标的注册情况：一项横断面元研究","url":"https://pubmed.ncbi.nlm.nih.gov/42977574","doi":"10.1111/dom.71483","pmid":"42977574","journal":"Diabetes Obes Metab","kind":"paper","lang":"en","published_at":"2026-11-03T00:00:00+00:00","fetched_at":"2026-11-08T03:44:04+00:00","authors":["Mondal R","Nandi M"],"primary_topic":"repro-endo","topics":[{"slug":"oocyte","score":1.0,"hits":["ovary"]},{"slug":"male","score":1.0,"hits":["semen"]},{"slug":"repro-endo","score":1.0,"hits":["polycystic ovary"]},{"slug":"repro-tox","score":1.0,"hits":["bmi"]}],"topic_score":1.0,"preference_score":0.0,"preference_labels":[],"llm_score":68.0,"final_score":68.0,"score_dims":{"novelty":72,"rigor":82,"impact":58,"relevance":56,"translation":55},"recommend_reason":"选题角度新颖，用元研究量化了减重药物试验中生殖安全性结局注册的系统性缺失，对GLP-1类药物生殖内分泌安全性讨论有提示价值；但属注册信息层面的方法学研究，不涉及生物学机制或ART操作，与辅助生殖核心实践距离较远，值得浏览而非必读。","keywords":["体重管理药物","试验注册","生殖结局","多囊卵巢综合征","GLP-1受体激动剂","元研究"],"selected":1,"story_id":138,"llm_provider":"deepseek","llm_model":"deepseek-flash","llm_effort":"low","source_key":"pubmed-endo-genetics","source_name":"PubMed · 生殖内分泌/遗传/保存","source_tier":1,"mention_count":1,"has_interpretation":false,"journal_key":null,"journal_tier":"unknown","journal_if":null,"is_mock":false,"summary_zh":"该研究于2026年8月31日检索ClinicalTrials.gov，纳入230项成人3期（含2/3期）药物减重随机对照试验（共91个研发项目、3711项注册结局），用已发表词典对结局字段分类，比较生殖结局与体成分指标的注册比例。结果仅2项试验（0.87%）注册了生殖结局，均为非工业界资助的多囊卵巢综合征人群；无生殖适应证试验（227项）无一注册。228项纳入男性的试验中无一注册男性性腺-内分泌或精液指标。33项注册体成分的试验中31项无任何生殖指标。结论：公开注册证据存在系统性缺口，并非未测量。","summary":"AIMS: To quantify registered reproductive outcome measures in women and men in adult Phase 3 weight-management pharmacotherapy trials and compare them with registered body-composition measures. MATERIALS AND METHODS: Cross-sectional meta-research study of ClinicalTrials.gov records as registered on 31 August 2026. Eligible trials were randomised, controlled, Phase 3 or 2/3, with registered minimum age ≥ 18 years, a pharmacological intervention, weight or BMI as a registered primary outcome and a weight-related registered condition. Registered outcome fields were classified with a published dictionary. Analyses used exact Clopper-Pearson intervals and paired counts; programme-level, mechanism and age-relaxed analyses were post hoc. RESULTS: Of 230 trials (91 development programmes; 3711 registered outcome measures), two registered any reproductive outcome measure (0.87%, 95% CI: 0.11-3.11), both in polycystic ovary syndrome populations with non-industry sponsors; none of 227 trials without a reproductive indication did. No trial enrolling men registered a named male gonadal-endocrine or semen measure (0/228, 95% CI: 0.00-1.60). Among trials of glucagon-like peptide-1-based agents it was 2/152 (1.32%). Body composition was registered in 33 trials, 31 without any reproductive measure and none the reverse; at programme level, 22 versus none. Admitting trials with minimum age below 18 years gave 7/254 (2.76%), including two industry trials registering gonadal hormones in adolescent safety panels. CONCLUSIONS: Qualifying reproductive outcomes were rarely registered in adult Phase 3 weight-management pharmacotherapy trials on ClinicalTrials.gov, including 31 of 33 trials registering body composition. This identifies a gap in publicly registered evidence, not absence of measurement; registering reproductive assessments where undertaken would improve their discoverability.","interpretation_basis":null,"fulltext_status":null,"interpretation":null,"fulltext":{"available":false,"status":null,"reason":"尚未抓取全文（未入选、分数未达阈值，或还没跑 fulltext 步骤）","pmcid":null,"license":null,"chars":0,"source":null,"fetched_at":null}}