CECT5713增加不明原因不孕症女性的足月妊娠率:一项随机、三盲、安慰剂对照试验。
CECT5713 Increases Term Pregnancies in Women with Infertility of Unknown Origin: A Randomized, Triple-Blind, Placebo-Controlled Trial.
作者信息
Huerga López Cristina, Sánchez Martín María J, Herráez Moreta Aránzazu, Calvo Urrutia Marta, Cristóbal García Ignacio, Díaz Morillo Cristina, Blanco-Rojo Ruth, Sáez María E, Olivares Mónica, Arroyo Rebeca, Herranz Carmen, Alba Claudio, Rodríguez Juan M, Fernández Leonides
机构信息
Hospital Clínico San Carlos, 28040 Madrid, Spain.
Kerry Group, Camino de Purchil 66, 18004 Granada, Spain.
出版信息
Nutrients. 2025 May 29;17(11):1860. doi: 10.3390/nu17111860.
Unexplained infertility is a worldwide problem affecting a significant proportion of couples of reproductive age. Recent studies suggest that alterations in the vaginal microbiota are related to female infertility, while supplementation with some probiotic strains has been shown to improve pregnancy rates in couples experiencing this problem. This study aimed to evaluate the impact of oral administration of CECT5713 on pregnancy success rates in couples with unexplained infertility prior to in vitro fertilization (IVF). : Seventy couples were randomized to receive either a placebo or a probiotic intervention (one capsule per day containing an excipient only or 3 × 10 viable cells of CECT5713 plus an excipient, respectively); 57 couples completed the study. Baseline data on demographics, health status (including gynecological and reproductive history), and lifestyle habits were collected. Vaginal swabs and semen samples were obtained from each couple before the intervention and immediately prior to IVF or upon confirmed pregnancy and were analyzed for microbiological (using both culture-dependent and -independent methods) and immunological profiles. : Oral administration of CECT5713 in couples with unexplained infertility scheduled for IVF resulted in a significantly higher pregnancy success rate (48.1%) compared to the placebo group (20.0%) (one-tailed Chi-square test; < 0.024). The probiotic intervention improved both vaginal and semen immunological profiles, with no substantial changes observed in their microbial composition. : These preliminary findings support the potential of CECT5713 supplementation to enhance fertility outcomes in couples with unexplained infertility.
不明原因不孕症是一个全球性问题,影响着相当比例的育龄夫妇。最近的研究表明,阴道微生物群的改变与女性不孕症有关,而补充一些益生菌菌株已被证明可以提高患有此问题的夫妇的妊娠率。本研究旨在评估口服CECT5713对不明原因不孕症夫妇在体外受精(IVF)前妊娠成功率的影响。70对夫妇被随机分为接受安慰剂或益生菌干预组(分别为每天一粒仅含辅料的胶囊或含3×10个CECT5713活细胞加辅料的胶囊);57对夫妇完成了研究。收集了人口统计学、健康状况(包括妇科和生殖史)以及生活习惯的基线数据。在干预前以及IVF前即刻或确认妊娠时从每对夫妇获取阴道拭子和精液样本,并分析其微生物学(使用依赖培养和不依赖培养的方法)和免疫学特征。对计划进行IVF的不明原因不孕症夫妇口服CECT5713,与安慰剂组(20.0%)相比,妊娠成功率显著更高(48.1%)(单尾卡方检验;P<0.024)。益生菌干预改善了阴道和精液的免疫学特征,其微生物组成未观察到实质性变化。这些初步研究结果支持补充CECT5713在提高不明原因不孕症夫妇生育结局方面的潜力。