The study was aimed to evaluate the safety and efficacy of cell therapy using autologous menstrual blood derived- mesenchymal stromal cells (Men-MSCs) in fertility potential of poor ovarian responders (PORs). POR women were divided into mesenchymal stroma cell (MSC) therapy (n = 15) and routine ICSI (n = 16) groups. The cultured Men-MSCs were autologously injected into left ovary of MSC group after approval by flow cytometry, karyotyping, endotoxin, sterility and mycoplasma tests. Changes in anti-Mullerian hormone (AMH), antral follicles count (AFC), oocytes and embryos number, clinical pregnancy rate and live birth rate were followed in both groups up to one year after treatment. 4 of 15 participants in MSC group got naturally pregnant during 3 months after cell administration, in contrast to no natural conception in control group (P = 0.04). The mean AMH level did not significantly differ with that of previous cycle or control group. Although mean AFC and oocytes number in MSC group did not indicate considerable difference with those of control group, raise of these parameters in comparison with previous cycle was significant (both P = 0.01). Nonetheless, oocyte fertilization rate and embryo number in MSC group were higher than control group (P = 0.04 and P = 0.008, respectively). Altogether, 7 of 15 women in MSC group and 2 of 16 women in routine ICSI group had clinical pregnancy that resulted in 5 live births in main group and one birth in control group. In conclusion, cell therapy using Men-MSCs could be considered as a potential treatment to restore fertility capability of POR women.The trial registration number (TRN): IRCT20180619040147N2.Date of registration: 2018-08-21.

中文翻译：

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通过卵巢内施用自体经血来源的间充质基质细胞改善卵巢反应较差的妊娠率和活产率：I / II期临床试验。

这项研究旨在评估使用自体经血来源的间充质基质细胞（Men-MSC）进行卵巢不良反应者（POR）的潜在生育能力的细胞治疗的安全性和有效性。POR妇女分为间充质基质细胞（MSC）治疗（n  = 15）和常规ICSI（n = 16）组。经流式细胞术，核型分析，内毒素，无菌和支原体检查批准后，将培养的Men-MSC自体注射到MSC组的左卵巢。两组均接受抗Mullerian激素（AMH），卵泡计数（AFC），卵母细胞和胚胎数量，临床妊娠率和活产率的变化，直至治疗后一年。MSC组的15名参与者中有4名在施用细胞后3个月内自然怀孕，而对照组则没有自然受孕（P = 0.04）。平均AMH水平与先前的周期或对照组无显着差异。尽管MSC组的平均AFC和卵母细胞数量与对照组没有显着差异，但与先前的周期相比，这些参数的升高是显着的（均P  = 0.01）。然而，MSC组卵母细胞受精率和胚胎数均高于对照组（P  = 0.04和P 分别为0.008）。MSC组15例妇女中有7例，常规ICSI组16例妇女中有2例临床妊娠，主要组有5例活产，对照组有1例。总之，使用Men-MSCs进行细胞疗法可被视为恢复POR妇女生育能力的潜在疗法。试验注册号（TRN）：IRCT20180619040147N2。注册日期：2018-08-21。