研究目的:
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虽然体外受精的优质胚胎率为 65%,但是其妊娠率仅为 30%-45%,分娩率仅为 20%,随着男女双方年龄的增长,成功率亦明显下降。 其中因男方因素导致试管婴儿失败者可高达40%。目前国内外有关影响试管婴儿失败后结局的研究主要集中于女方因素,但对男方因素的研究较少。受精是精子通过自身运动与卵子相遇,通过顶体反应、透明带反应等一系列复杂过程,最终形成受精卵。而精子密度低下、精子活力下降、形态异常,影响精子功能,使精卵结合受阻;同时精子运动能力直接影响胚胎的质量,当畸形精子和少、弱精症患者精液中的正常形态精子数量下降 4%时,可导致最大限度地降低受精率及着床率。由于精子质量欠佳导致受精率、卵裂率及优良胚胎形成率降低,从而导致试管婴儿失败的结局。由男方因素所导致的试管婴儿失败不少于试管婴儿失败的 40%,并且有相当数量的试管婴儿失败的病因不明且缺乏有效地治疗。对于男方因素致试管婴儿失败,现代医学至今尚无十分有效的治疗方法,多应用左卡尼汀、他莫昔芬、睾酮等药物进行经验性治疗。中医药在治疗试管婴儿失败后的男性不育症, 是从宏观上总体地协调机体内环境,研究发现中医药不但可以有效的提升试管婴儿失败后的男性不育症的精子参数,同时还能够达到促进早期胚胎的不断发育作用,使受精卵数和移植胚数能够明显增加使妊娠率提高。我们的前期临床研究表明:橘核活精方可以显著改善特发性弱精子症患者的精液常规、生精细胞凋亡率、精子 DNA 碎片率等参数,基于上述原因,我们进行此项研究,旨在探索橘核活精方结合现代医药技术时候具有提高辅助生殖的成功率的作用,并且期望为中医药结合现代高科技解决试管婴儿失败后的男性不育症的医学难题提供新的思路。
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Objectives of Study:
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Although the high quality embryo rate of in vitro fertilization is 65%, but its pregnancy rate is only 30%-45%, the delivery rate is only 20%, as the age of both men and women grows, the success rate also drops significantly. Among them, male factors cause up to 40% of IVF failures. At present, the domestic and foreign studies on the outcome of IVF failure mainly focus on female factors, but there are few studies on male factors. Fertilization is a process in which sperm meets egg through its own movement and finally forms zygote through a series of complex processes such as acrosome reaction and zona pellucida reaction. Low sperm density, decreased sperm motility and abnormal morphology affect sperm function and hinder sperm-egg union. At the same time, sperm motility directly affects the quality of embryos. When the number of abnormal sperm and normal sperm in semen of patients with oligospermia and asthenospermia decreases by 4%, the fertilization rate and implantation rate can be reduced to the maximum extent. Due to the poor quality of sperm, the fertilization rate, cleavage rate and good embryo formation rate are reduced, which leads to the failure of IVF. Male factors are responsible for no less than 40% of IVF failures, and a considerable number of IVF failures have unknown etiology and lack of effective treatment. For the failure of IVF caused by male factors, there is no very effective treatment method in modern medicine so far, and most drugs such as L-carnitine, tamoxifen and testosterone are used for empirical treatment. Traditional Chinese medicine in the treatment of male infertility after ivf failure, from on macroscopic overall coordinated by the environment, the study found that Chinese medicine not only can effectively improve ivf after the failure of the sperm parameters of male infertility, but also to promote the continuous development of early embryos, the zygote and embryo transplantation can significantly increase the pregnancy rate increased. Our preliminary clinical studies showed that: Orange nucleus activating sperm formula can significantly improve semen routine, spermatogenic cell apoptosis rate, sperm DNA fragmentation rate and other parameters in patients with idiopathic asthenospermia. Based on the above reasons, we conducted this study to explore the effect of orange nucleus activating sperm formula combined with modern medical technology on improving the success rate of assisted reproduction. And it is expected to provide new ideas for traditional Chinese medicine combined with modern high technology to solve the medical problem of male infertility after the failure of IVF.
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Inclusion criteria
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① Age 23-50 years old; ② Assisted reproduction failed once or more; ③ TCM syndrome differentiation is kidney deficiency damp-heat syndrome; ④ Normal sexual function; ⑤ Informed consent was signed, and volunteers were included in the observation.
The Western diagnostic criteria for male infertility, the diagnostic criteria for IVF failure and the TCM syndrome differentiation criteria for kidney deficiency and damp-heat can be referred to the research plan.
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Exclusion criteria:
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① Spouses with serious gynecological diseases can not exclude the impact on fertility or diagnosed infertility diseases; ② Erectile dysfunction, abnormal ejaculation; (3) Taking anti-epilepsy, anti-tumor drugs that hinder spermatogenesis and sperm motility; Genital congenital malformation, seminal tract obstruction, testicular atrophy, etc.; (5) Combined with cardiovascular, liver, kidney and hematopoietic system and other serious primary diseases; ⑥ Allergic constitution or allergic to the drug.
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