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Article(id=1322927074540925712, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.11.016, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793339993367, onlineDateStr=2026-10-30, pubDate=1762704000000, pubDateStr=2025-11-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793339993367, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793339993367, creator=13701087609, updateTime=1793339993367, updator=13701087609, issue=Issue{id=1322926985957221241, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='11', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1762704000000', pubDateStr='2025-11-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793339972247, creator='13701087609', updateTime=1793340743335, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322930220201804556, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322930220201804557, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=69, endPage=74, ext={EN=ArticleExt(id=1322927076117984017, articleId=1322927074540925712, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Effect of Kuntai Capsule（坤泰胶囊）Pretreatment Combined with Two Types of Cryopreservation Carriers on Embryo Transfer Outcomes in Patients with Diminished Ovarian Reserve, columnId=1256183361521967297, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Target on National Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To investigate the effect of Kuntai Capsule（坤泰胶囊）pretreatment combined with different cryopreservation carriers on embryo transfer outcomes in patients with diminished ovarian reserve（DOR）.

Methods

A retrospective analysis was conducted on 120 DOR patients undergoing in vitro fertilization（IVF）-frozen embryo transfer（FET）at the Reproductive Medicine Center of Huizhou Central People’s Hospital from January 2021 to October 2023. The patients were divided into four groups based on intervention：Group A［n＝30，conventional vitrification carrier（Cryotop）without herbal pretreatment］，Group B（n＝30，cryotop with Kuntai Capsule pretreatment），Group C［n＝30，novel tubular cryopreservation carrier（Tube Cryodevice Tiny-B1）without herbal pretreatment］，Group D（n＝30，Tiny-B1 with Kuntai Capsule pretreatment）. Groups B and D received Kuntai Capsule for three menstrual cycles. The parameters including anti Mullerian hormone（AMH），estradiol（E2），serum follicle stimulating hormone（FSH），endometrial thickness（ET），total antral follicle count，oocytes retrieved，high-quality embryos，embryo survival rate，implantation rate，clinical pregnancy rate，biochemical pregnancy rate and maternal-neonatal outcomes were compared. The data was analyzed using SPSS26.0.

Results

Baseline characteristics showed no significant differences among four groups（P>0.05）. After intervention，AMH level in Group D was significantly lower than those in Groups B and C（P＝0.012）；the E2 levels in Groups Cand D were higher than those in Groups A and B（P＝0.025）；the endometrial thickness in Group D exceeded that in the other groups（P<0.000 1）. Total antral follicles：the result of Group D was higher than that of Group A（35.7%，P＝0.003）and that of Group C（31.7%，P＝0.009）. Oocytes retrieved：the result of Group D surpassed that of Group A（P＝0.021）but showed no significant difference compared with that of Group B（P＝0.081）. High-quality embryos：the result of Group B increased by 34.2% compared with that of Group A（P＝0.016），while the result of Group D increased by 51.0% compared with that of Group C（P＝0.028）. Embryo survival rates showed no statistical difference（P>0.05），but implantation rates in Groups B and D were significantly higher than those in Groups A and C（P<0.05）. Clinical pregnancy rates in Groups B（70.00%）and D（73.33%）were significantly higher than those in Group A（50.00%）and Group C（53.33%）（P<0.05）. No differences in biochemical pregnancy rates were observed（P>0.05）. Live birth rates in Group D were markedly elevated compared with those in Group A（RR＝1.67，95% CI［1.12，2.47］，P＝0.004）. The live birth rates of Group B also improved compared with that of Group A（RR＝1.50，95% CI［1.02，2.21］，P＝0.021）. Neonatal preterm birth rates and birth weights showed no differences among four groups（P>0.05）.

Conclusion

Kuntai Capsule pretreatment improves ovarian function and endometrial receptivity in DORpatients，enhancing implantation and clinical pregnancy rates. Combined with the novel tubular cryopreservation carrier，Kuntai Capsule further increases oocyte yield，high-quality embryos and live birth rates.

, authors=Guangle CHEN1, Kaiyuan JI2, Limin LIU1, authorsList=Guangle CHEN, Kaiyuan JI, Limin LIU, authorCompany=null, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322927077028147992, articleId=1322927074540925712, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=坤泰胶囊预处理联合两种冷冻载杆对卵巢功能减退患者胚胎移植结局的影响, columnId=1256183362172142382, journalTitle=中华中医药学刊, columnName=国家项目点击, runingTitle=null, highlight=null, articleAbstract=
目的

研究坤泰胶囊预处理联合不同冷冻载杆对卵巢功能减退（Diminished ovarian reserve，DOR）患者胚胎移植结局的影响。

方法

回顾性分析2021年1月—2023年10月在惠州市中心人民医院生殖医学中心接受体外受精（In vitro fertilization，IVF）-冻胚移植（Frozen embryo transfer，FET）的120例DOR患者。患者按照干预方式分为4组：A组30例：传统玻璃化冷冻载杆（Cryotop），无中医预处理；B组30例：在Cryotop基础上接受坤泰胶囊预处理；C组30例：新型管式冷冻载杆（Tube cryodevice，Tiny-B1），无中医预处理；D组30例：Tiny-B1基础上接受坤泰胶囊预处理。B、D组患者接受坤泰胶囊预处理3个月经周期。比较4组患者的抗米勒管激素（AMH）、血清促卵泡激素水平（FSH）、雌二醇（E2）、子宫内膜厚度（ET）、窦卵泡总数、获卵数、优良胚胎数、胚胎复苏率、种植率、临床妊娠率、生化妊娠率及母婴结局。统计学方法采用SPSS 26.0分析数据。

结果

4组基线特征差异无统计学意义（P>0.05）。干预后D组的AMH水平显著低于B组和C组（P＝0.012）；C、D组E2水平高于A、B组（P＝0.025）；D组子宫内膜厚度明显高于其他组（P<0.000 1）。窦卵泡总数：D组显著高于A组（35.7%，P＝0.003），高于C组（31.7%，P＝0.009）；获卵数：D组高于A组（P＝0.021），但与B组相比差异无统计学意义（P＝0.081）；优良胚胎数：B组较A组提升34.2%（P＝0.016），D组较C组提升51.0%（P＝0.028）。胚胎复苏率差异无统计学意义（P>0.05），但B、D组种植率显著高于A、C组（P<0.05）。临床妊娠率B组、D组分别为70.00%、73.33%，显著高于A组（50.00%）和C组（53.33%）（P<0.05）。生化妊娠率差异无统计学意义（P>0.05）。活产率D组较A组显著提升（RR＝1.67，95%CI［1.12，2.47］，P＝0.004）；B组较A组提升（RR＝1.50，95%CI［1.02，2.21］，P＝0.021）。新生儿早产率、出生体质量4组间差异无统计学意义（P>0.05）。

结论

坤泰胶囊预处理可改善DOR患者的卵巢功能，提高子宫内膜容受性，增强种植率和临床妊娠率。在新型管式冷冻载杆的协同作用下，坤泰胶囊进一步提高了获卵数及优良胚胎数，提升了活产率。

, authors=陈光乐1, 冀开元2, 刘利敏1, authorsList=陈光乐, 冀开元, 刘利敏, authorCompany=null, correspAuthors=null, authorNote=

陈光乐（1990-），男，广东徐闻人，主管技师，硕士，研究方向：生殖医学。

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陈光乐（1990-），男，广东徐闻人，主管技师，硕士，研究方向：生殖医学。

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陈光乐（1990-），男，广东徐闻人，主管技师，硕士，研究方向：生殖医学。

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Hum Reprod Update，2021，27（4）：623-642., articleTitle=Immediate versus postponed frozen embryo transfer after IVF/ICSI：a systematic review and meta-analysis, refAbstract=null)], funds=[Fund(id=1322927082359108428, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, awardId=82002938, language=CN, fundingSource=国家自然科学基金项目(82002938), fundOrder=null, country=null), Fund(id=1322927082434605901, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, awardId=2024CZ010157, language=CN, fundingSource=惠州市科技计划项目(2024CZ010157), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322927077271417625, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, xref=1., ext=[AuthorCompanyExt(id=1322927077279806234, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, companyId=1322927077271417625, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Reproductive Medicine Center of Huizhou Central People's Hospital，Huizhou 516000，Guangdong，China), AuthorCompanyExt(id=1322927077288194843, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, companyId=1322927077271417625, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.惠州市中心人民医院，广东 惠州 516000)]), AuthorCompany(id=1322927077355303708, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, xref=2., ext=[AuthorCompanyExt(id=1322927077363692317, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, companyId=1322927077355303708, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Eighth Affiliated Hodpital，Sun Yat-sen University，Shenzhen 518033，Guangdong，China), AuthorCompanyExt(id=1322927077372080926, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, companyId=1322927077355303708, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.中山大学附属第八医院，广东 深圳 518033)])], figs=[ArticleFig(id=1322927080526197560, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=EN, label=null, caption=null, figureFileSmall=VG6jt+lTV9MuV17yQrLqgg==, figureFileBig=819FlHFC51WyICfD9NkTGg==, tableContent=null), ArticleFig(id=1322927080614277945, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=CN, label=图1, caption=研究路线图, figureFileSmall=VG6jt+lTV9MuV17yQrLqgg==, figureFileBig=819FlHFC51WyICfD9NkTGg==, tableContent=null), ArticleFig(id=1322927080849158970, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=EN, label=null, caption=null, figureFileSmall=e0TjhXw61RpzQALlcg5MEw==, figureFileBig=cmqqaQdTUk4kEPouWSiBXg==, tableContent=null), ArticleFig(id=1322927080920462139, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=CN, label=图2, caption=4组患者AMH、FSH和子宫内膜厚度（预处理前后）的分布情况, figureFileSmall=e0TjhXw61RpzQALlcg5MEw==, figureFileBig=cmqqaQdTUk4kEPouWSiBXg==, tableContent=null), ArticleFig(id=1322927080991765308, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数年龄/（岁）AMH/（ng/mL）FSH/（IU/L）AFC/（个）
A组3036.00±3.125.24±2.1110.50±3.566.85±2.40
B组3035.50±2.855.40±2.0810.40±3.347.10±2.35
C组3036.20±3.075.32±2.0610.30±3.306.75±2.15
D组3035.80±3.225.22±2.1510.40±3.507.00±2.30
), ArticleFig(id=1322927081067262781, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=CN, label=表1, caption=

两组患者基本信息情况比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数年龄/（岁）AMH/（ng/mL）FSH/（IU/L）AFC/（个）
A组3036.00±3.125.24±2.1110.50±3.566.85±2.40
B组3035.50±2.855.40±2.0810.40±3.347.10±2.35
C组3036.20±3.075.32±2.0610.30±3.306.75±2.15
D组3035.80±3.225.22±2.1510.40±3.507.00±2.30
), ArticleFig(id=1322927081138565950, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数年龄/（岁）AMH/（ng/mL）FSH（IU/L）E2/（pg/mL）ET/（mm）
治疗前Pre治疗后Post治疗前Pre治疗后Post治疗前Pre治疗后Post治疗前Pre治疗后Post
A组3036.00±3.125.24±2.113.34±0.9610.50±3.5611.05±3.2332.20±9.8729.09±7.156.85±2.459.77±2.12
B组3035.50±2.855.40±2.087.96±3.2110.40±3.3410.90±3.2031.50±9.1222.80±6.157.10±2.358.20±2.00
C组3036.20±3.075.32±2.066.42±2.8510.30±3.3010.60±3.1232.50±9.8036.05±8.406.75±2.158.20±2.20
D组3035.80±3.225.22±2.154.18±2.4510.40±3.5010.85±3.3033.00±9.6543.20±9.607.00±2.3010.52±2.25
F值-0.5810.3110.8180.3240.4560.6750.5690.43412.107
P值-0.6290.3240.0120.8080.7133.2340.0250.730<0.000 1
), ArticleFig(id=1322927081214063423, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=CN, label=表2, caption=

干预前后4组患者各指标变化比较

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组别例数年龄/（岁）AMH/（ng/mL）FSH（IU/L）E2/（pg/mL）ET/（mm）
治疗前Pre治疗后Post治疗前Pre治疗后Post治疗前Pre治疗后Post治疗前Pre治疗后Post
A组3036.00±3.125.24±2.113.34±0.9610.50±3.5611.05±3.2332.20±9.8729.09±7.156.85±2.459.77±2.12
B组3035.50±2.855.40±2.087.96±3.2110.40±3.3410.90±3.2031.50±9.1222.80±6.157.10±2.358.20±2.00
C组3036.20±3.075.32±2.066.42±2.8510.30±3.3010.60±3.1232.50±9.8036.05±8.406.75±2.158.20±2.20
D组3035.80±3.225.22±2.154.18±2.4510.40±3.5010.85±3.3033.00±9.6543.20±9.607.00±2.3010.52±2.25
F值-0.5810.3110.8180.3240.4560.6750.5690.43412.107
P值-0.6290.3240.0120.8080.7133.2340.0250.730<0.000 1
), ArticleFig(id=1322927081289560896, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数窦卵泡总数/（个）获卵数/（个）优良胚胎/（个）
A组3012.33±9.0111.47±7.093.30±2.44
B组3013.87±8.7513.40±9.304.43±2.76
C组3012.70±8.7412.53±5.983.00±2.12
D组3016.73±11.7715.10±9.964.53±4.01
F值4.123.782.95
P值0.0080.0120.035
), ArticleFig(id=1322927081360864065, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=CN, label=表3, caption=

4组患者窦卵泡总数、获卵数和优良胚胎数相比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数窦卵泡总数/（个）获卵数/（个）优良胚胎/（个）
A组3012.33±9.0111.47±7.093.30±2.44
B组3013.87±8.7513.40±9.304.43±2.76
C组3012.70±8.7412.53±5.983.00±2.12
D组3016.73±11.7715.10±9.964.53±4.01
F值4.123.782.95
P值0.0080.0120.035
), ArticleFig(id=1322927081448944450, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标组间对比均差95%CIP值
窦卵泡总数D vs A+4.40［1.21，7.59］0.003
D vs C+4.03［0.84，7.22］0.009
获卵数D vs A+3.63［0.45，6.81］0.021
B vs A+1.93［-1.25，5.11］0.314
优良胚胎数D vs C+1.53［0.11，2.95］0.028
), ArticleFig(id=1322927081516053315, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=CN, label=表4, caption=

4组窦卵泡总数、获卵数、优良胚胎数事后检验分析

, figureFileSmall=null, figureFileBig=null, tableContent=
指标组间对比均差95%CIP值
窦卵泡总数D vs A+4.40［1.21，7.59］0.003
D vs C+4.03［0.84，7.22］0.009
获卵数D vs A+3.63［0.45，6.81］0.021
B vs A+1.93［-1.25，5.11］0.314
优良胚胎数D vs C+1.53［0.11，2.95］0.028
), ArticleFig(id=1322927081604133700, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标载杆类型主效应（P值）坤泰胶囊主效应（P值）交互作用（P值）
窦卵泡总数0.0380.0090.012
获卵数0.0410.0180.026
优良胚胎数0.1070.0040.085
), ArticleFig(id=1322927081679631173, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927074540925712, language=CN, label=表5, caption=

4组窦卵泡总数、获卵数、优良胚胎数交互作用分析

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指标载杆类型主效应（P值）坤泰胶囊主效应（P值）交互作用（P值）
窦卵泡总数0.0380.0090.012
获卵数0.0410.0180.026
优良胚胎数0.1070.0040.085
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组别例数胚胎复苏率胚胎种植率
A组3096.67%（29/30）50.0%（15/30）
B组3096.67（29/30）73.33%（22/30）
C组30100.0%（30/30）60.0%（18/30）
D组30100.0%（30/30）80.00%（24/30）
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两组胚胎复苏率及种植率比较

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组别例数胚胎复苏率胚胎种植率
A组3096.67%（29/30）50.0%（15/30）
B组3096.67（29/30）73.33%（22/30）
C组30100.0%（30/30）60.0%（18/30）
D组30100.0%（30/30）80.00%（24/30）
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组别例数临床妊娠率生化妊娠率
A组3050.00%（15/30）6.67%（2/30）
B组3070.00%（21/30）6.67%（2/30）
C组3053.33%（16/30）6.67%（2/30）
D组3073.33%（22/30）3.33%（1/30）
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两组临床妊娠率及生化妊娠率比较

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组别例数临床妊娠率生化妊娠率
A组3050.00%（15/30）6.67%（2/30）
B组3070.00%（21/30）6.67%（2/30）
C组3053.33%（16/30）6.67%（2/30）
D组3073.33%（22/30）3.33%（1/30）
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组别早产率新生儿体质量/（g）活产率
A组20.00%（3/15）3350±25240.0%（12/30）
B组9.52%（2/21）3405±27860.00%（18/30）
C组18.75%（3/16）3360±27143.33%（13/30）
D组4.55%（1/22）3420±28266.67%（20/30）
χ2/t6.83*1.23**8.94*
P值0.0780.3020.030
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两组母婴结局及新生儿健康比较

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组别早产率新生儿体质量/（g）活产率
A组20.00%（3/15）3350±25240.0%（12/30）
B组9.52%（2/21）3405±27860.00%（18/30）
C组18.75%（3/16）3360±27143.33%（13/30）
D组4.55%（1/22）3420±28266.67%（20/30）
χ2/t6.83*1.23**8.94*
P值0.0780.3020.030
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坤泰胶囊预处理联合两种冷冻载杆对卵巢功能减退患者胚胎移植结局的影响
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陈光乐 1 , 冀开元 2 , 刘利敏 1
中华中医药学刊 | 国家项目点击 2025,43(11): 69-74
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中华中医药学刊 |国家项目点击 2025 , 43 (11) : 69 -74
坤泰胶囊预处理联合两种冷冻载杆对卵巢功能减退患者胚胎移植结局的影响
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陈光乐（1990-），男，广东徐闻人，主管技师，硕士，研究方向：生殖医学。

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陈光乐（1990-），男，广东徐闻人，主管技师，硕士，研究方向：生殖医学。

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陈光乐1, 冀开元2, 刘利敏1
作者信息
  • 1.惠州市中心人民医院，广东 惠州 516000
  • 2.中山大学附属第八医院，广东 深圳 518033
作者简介:

陈光乐（1990-），男，广东徐闻人，主管技师，硕士，研究方向：生殖医学。

Effect of Kuntai Capsule（坤泰胶囊）Pretreatment Combined with Two Types of Cryopreservation Carriers on Embryo Transfer Outcomes in Patients with Diminished Ovarian Reserve
Guangle CHEN1, Kaiyuan JI2, Limin LIU1
Affiliations
  • 1.Reproductive Medicine Center of Huizhou Central People's Hospital，Huizhou 516000，Guangdong，China
  • 2.The Eighth Affiliated Hodpital，Sun Yat-sen University，Shenzhen 518033，Guangdong，China
出版时间: 2025-11-10 doi: 10.13193/j.issn.1673-7717.2025.11.016
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摘要
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目的

研究坤泰胶囊预处理联合不同冷冻载杆对卵巢功能减退（Diminished ovarian reserve，DOR）患者胚胎移植结局的影响。

方法

回顾性分析2021年1月—2023年10月在惠州市中心人民医院生殖医学中心接受体外受精（In vitro fertilization，IVF）-冻胚移植（Frozen embryo transfer，FET）的120例DOR患者。患者按照干预方式分为4组：A组30例：传统玻璃化冷冻载杆（Cryotop），无中医预处理；B组30例：在Cryotop基础上接受坤泰胶囊预处理；C组30例：新型管式冷冻载杆（Tube cryodevice，Tiny-B1），无中医预处理；D组30例：Tiny-B1基础上接受坤泰胶囊预处理。B、D组患者接受坤泰胶囊预处理3个月经周期。比较4组患者的抗米勒管激素（AMH）、血清促卵泡激素水平（FSH）、雌二醇（E2）、子宫内膜厚度（ET）、窦卵泡总数、获卵数、优良胚胎数、胚胎复苏率、种植率、临床妊娠率、生化妊娠率及母婴结局。统计学方法采用SPSS 26.0分析数据。

结果

4组基线特征差异无统计学意义（P>0.05）。干预后D组的AMH水平显著低于B组和C组（P＝0.012）；C、D组E2水平高于A、B组（P＝0.025）；D组子宫内膜厚度明显高于其他组（P<0.000 1）。窦卵泡总数：D组显著高于A组（35.7%，P＝0.003），高于C组（31.7%，P＝0.009）；获卵数：D组高于A组（P＝0.021），但与B组相比差异无统计学意义（P＝0.081）；优良胚胎数：B组较A组提升34.2%（P＝0.016），D组较C组提升51.0%（P＝0.028）。胚胎复苏率差异无统计学意义（P>0.05），但B、D组种植率显著高于A、C组（P<0.05）。临床妊娠率B组、D组分别为70.00%、73.33%，显著高于A组（50.00%）和C组（53.33%）（P<0.05）。生化妊娠率差异无统计学意义（P>0.05）。活产率D组较A组显著提升（RR＝1.67，95%CI［1.12，2.47］，P＝0.004）；B组较A组提升（RR＝1.50，95%CI［1.02，2.21］，P＝0.021）。新生儿早产率、出生体质量4组间差异无统计学意义（P>0.05）。

结论

坤泰胶囊预处理可改善DOR患者的卵巢功能，提高子宫内膜容受性，增强种植率和临床妊娠率。在新型管式冷冻载杆的协同作用下，坤泰胶囊进一步提高了获卵数及优良胚胎数，提升了活产率。

坤泰胶囊  /  卵巢功能减退  /  新型管式冷冻载杆  /  冷冻胚胎移植  /  子宫内膜容受性
Objective

To investigate the effect of Kuntai Capsule（坤泰胶囊）pretreatment combined with different cryopreservation carriers on embryo transfer outcomes in patients with diminished ovarian reserve（DOR）.

Methods

A retrospective analysis was conducted on 120 DOR patients undergoing in vitro fertilization（IVF）-frozen embryo transfer（FET）at the Reproductive Medicine Center of Huizhou Central People’s Hospital from January 2021 to October 2023. The patients were divided into four groups based on intervention：Group A［n＝30，conventional vitrification carrier（Cryotop）without herbal pretreatment］，Group B（n＝30，cryotop with Kuntai Capsule pretreatment），Group C［n＝30，novel tubular cryopreservation carrier（Tube Cryodevice Tiny-B1）without herbal pretreatment］，Group D（n＝30，Tiny-B1 with Kuntai Capsule pretreatment）. Groups B and D received Kuntai Capsule for three menstrual cycles. The parameters including anti Mullerian hormone（AMH），estradiol（E2），serum follicle stimulating hormone（FSH），endometrial thickness（ET），total antral follicle count，oocytes retrieved，high-quality embryos，embryo survival rate，implantation rate，clinical pregnancy rate，biochemical pregnancy rate and maternal-neonatal outcomes were compared. The data was analyzed using SPSS26.0.

Results

Baseline characteristics showed no significant differences among four groups（P>0.05）. After intervention，AMH level in Group D was significantly lower than those in Groups B and C（P＝0.012）；the E2 levels in Groups Cand D were higher than those in Groups A and B（P＝0.025）；the endometrial thickness in Group D exceeded that in the other groups（P<0.000 1）. Total antral follicles：the result of Group D was higher than that of Group A（35.7%，P＝0.003）and that of Group C（31.7%，P＝0.009）. Oocytes retrieved：the result of Group D surpassed that of Group A（P＝0.021）but showed no significant difference compared with that of Group B（P＝0.081）. High-quality embryos：the result of Group B increased by 34.2% compared with that of Group A（P＝0.016），while the result of Group D increased by 51.0% compared with that of Group C（P＝0.028）. Embryo survival rates showed no statistical difference（P>0.05），but implantation rates in Groups B and D were significantly higher than those in Groups A and C（P<0.05）. Clinical pregnancy rates in Groups B（70.00%）and D（73.33%）were significantly higher than those in Group A（50.00%）and Group C（53.33%）（P<0.05）. No differences in biochemical pregnancy rates were observed（P>0.05）. Live birth rates in Group D were markedly elevated compared with those in Group A（RR＝1.67，95% CI［1.12，2.47］，P＝0.004）. The live birth rates of Group B also improved compared with that of Group A（RR＝1.50，95% CI［1.02，2.21］，P＝0.021）. Neonatal preterm birth rates and birth weights showed no differences among four groups（P>0.05）.

Conclusion

Kuntai Capsule pretreatment improves ovarian function and endometrial receptivity in DORpatients，enhancing implantation and clinical pregnancy rates. Combined with the novel tubular cryopreservation carrier，Kuntai Capsule further increases oocyte yield，high-quality embryos and live birth rates.

Kuntai Capsule（坤泰胶囊）  /  diminished ovarian reserve  /  tubular cryopreservation carrier  /  frozen embryo transfer  /  endometrial receptivity
陈光乐, 冀开元, 刘利敏. 坤泰胶囊预处理联合两种冷冻载杆对卵巢功能减退患者胚胎移植结局的影响. 中华中医药学刊, 2025 , 43 (11) : 69 -74 . DOI: 10.13193/j.issn.1673-7717.2025.11.016
Guangle CHEN, Kaiyuan JI, Limin LIU. Effect of Kuntai Capsule（坤泰胶囊）Pretreatment Combined with Two Types of Cryopreservation Carriers on Embryo Transfer Outcomes in Patients with Diminished Ovarian Reserve[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (11) : 69 -74 . DOI: 10.13193/j.issn.1673-7717.2025.11.016
正文
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卵巢功能减退（Diminished ovarian reserve，DOR）是一种影响女性生育能力的疾病，表现为卵巢储备的减少，进而导致生育能力下降[1-2]。根据统计，DOR患者的妊娠率显著低于正常卵巢功能的女性，对患者的生育能力造成影响，也给她们的情感和经济带来了巨大负担[3]。当前的治疗手段主要包括促排卵药物[4]和体外受精（In vitro fertilization，IVF）[5]，但在某些情况下，这些方法的效果有限，并可能伴随一定的不良反应[6]。因此，探索新的治疗方案以提高DOR患者的妊娠结局显得尤为必要[7]。近年来的研究表明，中医药在改善卵巢功能和提升妊娠率方面具有一定的潜力，尤其是像坤泰胶囊这样的中药制剂已显示出对DOR患者的潜在益处[8-9]，尽管已有一些初步的临床证据，但针对其具体机制和效果的研究仍然不足[10]。因此，揭示中医药在DOR患者胚胎移植中的作用机制，以及与现代医学技术的结合，成为当前研究的重点。
本研究旨在探讨坤泰胶囊的预处理对DOR患者的影响，尤其是其与两种不同冷冻载杆的联合应用。我们采用随机对照试验的方法，招募120名符合DOR诊断标准的患者，评估坤泰胶囊预处理及冷冻载杆对胚胎移植结局的影响。这种研究设计的优势在于能够有效控制多种变量，从而提供更为可靠的结果，有助于确定不同冷冻载杆对胚胎存活率、妊娠率和活产率的影响，从而为DOR患者的治疗提供更为有效的方案。在本研究中，我们将深入分析患者的特征、治疗方案、药物效果、不良反应及预后评估。通过比较坤泰胶囊与不同冷冻载杆的组合治疗效果，我们希望能够为DOR患者的个性化治疗提供新的思路和依据。此外，研究结果将为后续的机制研究提供支持，进一步推动中西医结合的临床应用。DOR是一种复杂的生理病理现象，其影响因素众多且相互交织。通过本研究，我们期望能够为改善DOR患者的生育能力提供新的治疗策略，并为未来的研究提供基础数据和理论支持，以期能够缓解患者的生育压力。
1　资料与方法
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1.1　一般资料
回顾性分析惠州市中心人民医院生殖医学中心2021年1月—2023年10月接受IVF-冻胚移植（Frozen embryo transfer，FET）的患者。共纳入120例符合DOR诊断标准的患者，取卵日女方年龄≤38岁，均自愿接受干预方案分配治疗。根据干预方式分为4组：A组30例：采用传统玻璃化冷冻载杆（Cryotop），无中医预处理。B组30例：采用Cryotop基础上接受坤泰胶囊（规格：0.5 g×24粒/盒；国药准字Z20000083）预处理。C组30例：采用新型管式冷冻载杆（Tube Cryodevice，Tiny-B1），无中医预处理。D组30例：采用Tiny-B1基础上接受坤泰胶囊预处理。具体研究线路见图1。
1.2　纳入标准
①FET周期；②取卵日女方年龄为≤38岁；③卵巢对促性腺激素刺激有正常反应；④女方内膜>7 mm。⑤不孕因素为女方输卵管因素、男方因素及其他原因导致的不孕。
1.3　排除标准
①取卵日女方>38岁；②女方卵巢储备功能低下；③夫妻一方或双方染色体异常；④不孕因素排除因女方内膜因素（盆腔及子宫内膜异位症、子宫肌、子宫肌瘤等）及其他疾病因素（多囊卵巢综合征等）而导致的不孕；⑤签署知情同意书，自愿接受坤泰胶囊预处理及FET治疗。
1.4　诊断标准
DOR西医诊断标准：依据欧洲人类生殖与胚胎学会（ESHRE）共识[11]。中医诊断标准：参照《中医妇科学》及卵巢储备功能减退共识[12-13]，由两名副主任中医师评估。
1.5　预处理
所有患者接受常规序贯口服芬吗通（雌二醇片/雌二醇地屈孕酮片，2/10 mg），前14 d服用红色片（雌二醇2 mg/d），后14 d服用灰色片（雌二醇2 mg/d，地屈孕酮10 mg/d），28 d为1个疗程，均连续服药3个疗程。B组和D组患者在常规基础上接受坤泰胶囊（0.5 g×24粒/盒，国药准字Z20000083，贵阳新天药业股份有限公司）预处理3个月经周期，4粒/次，3次/d，餐后30 min温水送服。并详细记录。
1.6　疗效评价标准
比较其卵泡总数、获卵数、优良胚胎数、复苏率、临床妊娠率、胚胎种植率、生化妊娠率、异位妊娠率、流产率、活产率的差异。
主要观察指标：临床结局依据2017年美国生殖医学学会（ASRM）共识标准评估。移植后14 d随访血清β-hCG，主要结局包括胚胎复苏率、临床妊娠率、活产率。①胚胎复苏率：每100个解冻胚胎中存活的比例。②临床妊娠率：移植后超声证实至少1个妊娠囊并检测到胎心（包括异位妊娠），计算为每100个移植周期的临床妊娠数。③活产率：怀孕≥22周后至少分娩一个胎儿的比例，按每100个移植周期计算。
次要观察指标：①窦卵泡总数：通过经阴道超声在月经周期第2～4天对双侧卵巢的窦卵泡（直径2～9 mm）进行计数，反映卵巢储备功能。获卵数：在超声引导下穿刺卵泡后，从卵泡液中分离并计数形态完整的成熟卵母细胞（MII期），直接反映促排卵效果。优良胚胎数：卵裂期胚胎（第3天）：细胞数≥6且均匀、碎片率≤10%；囊胚（第5～6天）：根据Gardner评分系统，选择扩张状态（≥3期）、内细胞团（A/B级）和滋养层（A/B级）发育良好的囊胚。②胚胎种植率：移植后囊胚附着并形成妊娠囊的比率。③生化妊娠率：血尿β-hCG（≥25 IU/mL）阳性但无超声可见妊娠囊者，每100个移植周期计算。④早产率：早产指妊娠满28周（196 d）但不足37周（259 d）的分娩。早产率是某一时间段内早产儿数量占同期所有活产儿总数的比例。计算公式：早产率＝早产儿数/同期活产儿总数×100%。⑤活产率：活产指胎儿娩出母体后具有以下任一生理现象：自主呼吸、心跳、脐带搏动、明确的随意肌收缩，活产率是某一时间段内活产儿数占同期所有分娩数（活产＋死产）的比例。计算公式：活产率＝活产儿数/同期总分娩数（活产＋死产）×100%。
1.7　统计分析
所有数据均使用SPSS 26.0统计软件进行分析。计量资料［患者年龄、抗米勒管激素（AMH）水平、基础血清促卵泡激素水平（FSH）、窦卵泡总数（AFC）等］采用正态性检验，符合正态分布，则以均数±标准差（）表示，并采用独立样本t检验进行两组间比较；不符合正态分布，则采用Mann-Whitney U检验。方差分析（ANOVA）：用于比较不同组别之间的均值差异。多重比较采用Tukey HSD检验对各组之间的差异进行进一步比较。计数资料（临床妊娠率、生化妊娠率、异位妊娠率、流产率、活产率等）以例数（百分比）表示，采用卡方检验（χ2检验）或Fisher精确检验进行组间比较。所有统计检验均为双侧检验，以P<0.05认为差异具有统计学意义。
2　结果
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2.1　基线特征比较
两组患者在年龄、AMH水平、基础FSH水平、AFC数等基线特征方面进行比较。结果显示，4组间各项基线特征差异均无统计学意义（P>0.05），提示组间可比性，见表1。
2.2　干预前后不同指标变化
干预前后，4组患者不同指标变化：AMH（Post-AMH）：D组的Post-AMH水平显著低于B组和C组（P＝0.012），提示坤泰胶囊预处理可能对AMH产生影响。雌二醇（E2）（Post-E2）：C组和D组的E2水平显著高于A组和B组（P＝0.025），表明预处理对内分泌的影响更为显著。子宫内膜厚度：D组的子宫内膜厚度显著高于其他组别（P<0.000 1），表明预处理对子宫内膜的改善作用更为明显，见表2。AMH水平（Pre-AMH与Post-AMH）：在Post-AMH的箱线图中可以看出，部分组别（如C组和D组）的AMH值有显著的波动，可能表明预处理对AMH水平的影响。FSH水平（Pre-FSH与Post-FSH）：FSH水平在各组间的差异较小，表明预处理对于FSH水平的影响较小。子宫内膜厚度（ET）：在子宫内膜厚度的后处理图中，D组的子宫内膜厚度明显提高，表明坤泰胶囊与新型冷冻载杆联合使用对内膜厚度有显著改善作用，见插页Ⅸ图2。
4组患者窦卵泡总数、获卵数和优良胚胎数相比较，窦卵泡总数：新型载杆＋坤泰胶囊（D组）显著优于传统方案（A/C组）：D组窦卵泡数比A组高35.7%（P＝0.003），比C组高31.7%（P＝0.009），提示新型冷冻载杆与坤泰胶囊可能存在协同增效作用。坤泰胶囊单独作用（B vs A）未达统计学差异（P＝0.210）。获卵数：D组表现最优：D组获卵数显著高于A组（P＝0.021），但未显著优于B组（P＝0.081）。新型载杆单独作用（C vs A）无显著提升（P＝0.452），需结合中药增效。优良胚胎数：坤泰胶囊效果明确：B组优良胚胎数比A组高34.2%（P＝0.016），D组比C组高51.0%（P＝0.028）。新型载杆单独作用（Cvs A）无优势（P＝0.62），需联合中药（见表3）。进一步对4组患者窦卵泡总数、获卵数、优良胚胎数进行事后检验结果详见表4；4组患者窦卵泡总数、获卵数、优良胚胎数交互作用分析结果表明新型载杆与坤泰胶囊在窦卵泡总数和获卵数上存在显著协同作用（交互作用P<0.05），见表5。
2.3　胚胎复苏率及种植率比较
4组间胚胎复苏率结果相比较，差异不具有统计学意义（P>0.05），B组和D组的胚胎种植率高于A组和C组，D组与ABC 3组的胚胎种植率比较显示：与A组（50.0%）相比，D组（80.0%）种率显著更高（χ2 ＝6.000，P＝0.014）；与C组（60.0%）相比，D组仍具优势（χ2＝4.800，P＝0.028），D组（80.00%）优于B组（73.33%），但差异无统计学意义（χ2＝0.469，P＝0.493），组间差异具有统计学意义（P<0.05），见表6。
2.4　临床妊娠率及生化妊娠率比较
B组和D组的临床妊娠率分别为70.00%、73.33%，显著高于A组和C组的50.00%和53.33%（P<0.05）。D组的临床妊娠率优于B组，但组间差异无统计学意义（χ2＝0.082，P＝0.774）。生化妊娠率在4组间的差异无统计学意义（P>0.05），见表7。
2.5　母婴结局及新生儿健康
在新生儿健康方面，4组的早产率、新生儿出生体质量差异无统计学意义（P>0.05）。B组和D组活产率表现较好，活产率两两比较（校正后α＝0.008）：D组vs A组：RR＝1.67（95%CI［1.12，2.47］，P＝0.004（显著提升活产率）；B组vs A组：RR＝1.50（95%CI［1.02，2.21］，P＝0.021（边缘性显著），差异具有统计学意义（P<0.05）。新生儿体质量两因素交互作用结果显示载杆类型与坤泰胶囊对新生儿体质量无交互效应（P＝0.421），新生儿健康未见显著差异，见表8。
3　讨论
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DOR是导致女性不孕的重要因素之一[14-15]，其特征为窦卵泡减少、卵巢储备功能下降及胚胎质量下降，严重影响胚胎移植结局[16-17]。近年来，辅助生殖技术不断发展，但DOR患者的临床妊娠率及活产率仍较低[18-19]。因此，如何优化DOR患者的促排卵及胚胎移植方案，提高其妊娠结局，是临床关注的重点。本研究探讨了坤泰胶囊预处理联合两种不同冷冻载杆对DOR患者胚胎移植结局的影响。卵巢功能减退在中医属“经水早断”“血枯”范畴，其病机核心在于肾精亏虚累及天癸化生，兼夹肝郁血瘀、脾虚痰湿等病理因素，导致“肾-天癸-冲任-胞宫轴”功能紊乱（对应现代医学下丘脑-垂体-卵巢轴失调）。现代研究证实该病与卵泡颗粒细胞线粒体功能障碍、氧化应激及自噬异常密切相关，采用补肾养阴中药可通过调控SIRT1/PGC-1α通路改善卵巢储备功能，还能纠正卵巢局部微循环障碍，体现中医整体调节与靶向干预的结合优势。
3.1　坤泰胶囊对卵巢功能及内分泌的影响
坤泰胶囊是基于补肾养阴理论研制的中成药，其组方包括熟地黄、黄连、白芍、黄芩、阿胶及茯苓，主要具有滋阴清热、调节内分泌、改善卵巢功能的作用[20-22]。本研究结果提示，D组（新型冷冻载杆＋坤泰胶囊预处理）患者的AMH水平在干预后低于B组和C组（P＝0.012），提示坤泰胶囊可能影响AMH水平的动态变化。此外，E2水平在C组和D组显著升高（P＝0.025），提示坤泰胶囊在新型冷冻载杆的协同作用下，对内分泌的调节作用更为显著。研究结果提示，坤泰胶囊可通过调节下丘脑-垂体-卵巢轴（HPO轴）功能，改善卵泡生长环境，提高卵巢对促排卵药物的反应性。本研究中，D组患者的子宫内膜厚度显著高于其他组别（P<0.000 1），提示坤泰胶囊可能通过改善子宫内膜容受性，提高胚胎着床率[23-24]。这与既往研究结果一致，即补肾养阴药物可改善子宫内膜的血流供应和雌激素反应，提高子宫内膜的厚度和容受性。
3.2　冷冻载杆类型与坤泰胶囊的协同作用
本研究比较了Cryotop和Tiny-B1的临床效果。结果显示，在窦卵泡总数、获卵数和优良胚胎数方面，D组显著优于A组和C组（P<0.05），提示新型冷冻载杆与坤泰胶囊可能具有协同增效作用。冷冻胚胎复苏后，其发育潜能受到多种因素影响，如冷冻载杆的设计、冷冻保护剂的选择及患者自身的内分泌环境[25-27]。新型管式冷冻载杆采用封闭系统，减少了操作误差和环境影响，有助于提高胚胎存活率和发育潜能。此外，D组患者的胚胎种植率显著高于A组和C组（P<0.05），提示新型载杆与坤泰胶囊的联合应用可能更有利于胚胎的成功植入。
3.3　临床妊娠率及生化妊娠率的影响
研究数据显示，B组和D组的临床妊娠率（70.00%、73.33%）显著高于A组和C组（50.00%、53.33%，P<0.05），其中D组的临床妊娠率优于B组。这说明坤泰胶囊的预处理可能在提高DOR患者妊娠率方面具有积极作用，尤其在新型冷冻载杆的辅助下，其疗效更为明显。生化妊娠率在4组间的差异无统计学意义（P>0.05），提示坤泰胶囊的主要作用可能在于提高胚胎的着床和维持妊娠[28]，而非影响早期妊娠的生化过程。这与既往研究结论一致，即补肾中药通过调节子宫内环境，增强胚胎种植能力，提高临床妊娠率[29-31]。
3.4　母婴结局及新生儿健康
在新生儿健康方面，本研究发现4组间的早产率和新生儿出生体质量差异无统计学意义（P>0.05）。但B组和D组的活产率较A组和C组显著提高（P<0.05），其中D 组活产率（66.67%）显著高于A 组（40.00%，P＝0.004）。这表明坤泰胶囊预处理可能通过改善妊娠维持环境[32-33]，提高DOR患者的活产率。新生儿体质量的分析结果显示，冷冻载杆类型与坤泰胶囊之间无显著交互效应（P＝0.421），提示新型冷冻载杆的主要作用可能集中在胚胎复苏和移植阶段[25，34-36]，而对妊娠后期胎儿生长的影响较小。
3.5　研究局限性与展望
本研究的局限性主要是样本量相对较小，研究结果需进一步验证。另外，DOR患者的病因复杂，影响其妊娠结局的因素较多，未来研究可结合基因组学、代谢组学等多组学方法，探讨坤泰胶囊改善卵巢储备功能及妊娠结局的机制。
综上所述，本研究结果表明，坤泰胶囊预处理可改善DOR患者的内分泌状态、提高子宫内膜容受性，并在新型冷冻载杆的协同作用下显著提高胚胎种植率和临床妊娠率。未来仍需进一步扩大样本量，开展多中心研究，以验证本研究结论并优化DOR患者的辅助生殖治疗方案。
基金
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  • 国家自然科学基金项目(82002938)
  • 惠州市科技计划项目(2024CZ010157)
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2025年第43卷第11期
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doi: 10.13193/j.issn.1673-7717.2025.11.016
  • 首发时间：2026-10-30
  • 出版时间：2025-11-10
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国家自然科学基金项目(82002938)
惠州市科技计划项目(2024CZ010157)
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    1.惠州市中心人民医院，广东 惠州 516000
    2.中山大学附属第八医院，广东 深圳 518033
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2种不同金属材料的力学参数
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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