Seyihoglu Burakhan, Gucuk Sude, Can Alp
Laboratories for Stem Cells and Reproductive Cell Biology, Department of Histology and Embryology, Ankara University School of Medicine, Sihhiye, Ankara, 06230, Turkey.
J Assist Reprod Genet. 2025 Jul 24. doi: 10.1007/s10815-025-03599-y.
To evaluate the efficacy, safety, and limitations of cellular therapy in primary ovarian insufficiency (POI) and poor ovarian response (POR).
A comprehensive search was conducted through the PubMed, Scopus, Web of Science, and Cochrane databases. The study type was limited to clinical trials, pilot studies, and case reports performed on human patients. Animal experiments, in vitro studies, correlational and longitudinal studies, and study designs and protocols were excluded. Twenty-seven studies with 694 patients from 2014 were found by May 2025.
Most studies (59.3%) were from Asia, and 77.8% lacked control groups. Autologous bone marrow mesenchymal stem/stromal cells (MSCs) were used in 37% of studies, rising to 51.8% when combined with platelet-rich plasma. Intraovarian injection was the most common delivery method (70.3%), administered laparoscopically (29.6%), or transvaginally (37%). Follow-up durations of 7-12 months were most common (40.7%). Pregnancy outcomes were reported in 59.2% of studies with control groups. Of the 522 patients treated, 60 (11.7%) became pregnant, compared to 13 (7.6%) of 172 controls. In two-arm studies (22.2% of all), the pregnancy rate was 22.6% (40 patients). Menstruation resumed in 37 (7.1%) of 522 treated patients, dropping to 5.1% in controlled studies.
Variability in sample sizes and protocols affects the reliability of findings. Larger trials and standardized protocols for cell type, delivery, and outcomes are essential. Seven to twelve months of follow-up seems suitable for evaluating efficacy but may not be optimal for evaluating the safety. Stratifying patients by age, cause, and reserve could improve outcomes.
Prospero (ID: CRD420251047104).
评估细胞疗法在原发性卵巢功能不全（POI）和卵巢低反应（POR）中的疗效、安全性及局限性。
通过PubMed、Scopus、Web of Science和Cochrane数据库进行全面检索。研究类型限于针对人类患者的临床试验、试点研究和病例报告。排除动物实验、体外研究、相关性和纵向研究以及研究设计和方案。截至2025年5月，共找到2014年以来涉及694例患者的27项研究。
大多数研究（59.3%）来自亚洲，77.8%的研究缺乏对照组。37%的研究使用自体骨髓间充质干细胞（MSCs），与富含血小板血浆联合使用时这一比例升至51.8%。卵巢内注射是最常见的给药方式（70.3%），通过腹腔镜给药（29.6%）或经阴道给药（37%）。最常见的随访时长为7 - 12个月（40.7%）。59.2%有对照组的研究报告了妊娠结局。在接受治疗的522例患者中，60例（11.7%）怀孕，而172例对照组患者中有13例（7.6%）怀孕。在双臂研究中（占所有研究的22.2%），妊娠率为22.6%（40例患者）。522例接受治疗的患者中有37例（7.1%）月经恢复，在对照研究中这一比例降至5.1%。
样本量和方案的差异影响研究结果的可靠性。开展更大规模的试验以及针对细胞类型、给药方式和结局制定标准化方案至关重要。7至12个月的随访似乎适合评估疗效，但可能并非评估安全性的最佳时长。按年龄、病因和储备对患者进行分层可能会改善结局。
Prospero（编号：CRD420251047104）
