研究疾病:
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多囊卵巢综合征
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研究疾病代码:
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Target disease:
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Polycystic Ovary Syndrome
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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通过随机平行对照研究,对补肾解郁调冲中药治疗PCOS排卵障碍性不孕患者的临床疗效性、安全性进行分析,对比西药克罗米芬促排卵治疗PCOS排卵障碍性不孕,观察补肾解郁调冲中药在改善临床妊娠率、周期排卵率、生殖内分泌指标,降低LUFS、OHSS发生率等方面的作用,并分析其治疗优势,为PCOS排卵障碍性不孕的临床治疗提供更优的干预疗法。将神经递质作为结局指标之一,从心理应激角度探讨补肾解郁调冲中药治疗PCOS排卵障碍性不孕的相关生物学机制。
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Objectives of Study:
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The clinical efficacy and safety of traditional Chinese medicine for treating ovulation disorder infertility of PCOS were analyzed by randomized parallel control study. The clinical efficacy and safety of clomiphene were compared to that of clomiphene in the treatment of ovulation disorder infertility of PCOS, and the effects of traditional Chinese medicine on improving clinical pregnancy rate, cycle ovulation rate, reproductive endocrine index, and reducing the incidence of LUFS and OHSS were observed The effect of the treatment was analyzed, and the better intervention therapy was provided for the clinical treatment of PCOS ovulation disorder infertility.Taking neurotransmitter as one of the outcome indicators, the biological mechanism of tonifying kidney, relieving depression and regulating Chong in treating infertility with ovulation disorder in PCOS was studied from the perspective of psychological stress.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)年龄 20-40 岁,有生育要求者;
(2)符合 PCOS 及排卵障碍性不孕症西医诊断标准及中医肾虚肝郁证辨证标准的患者;
(3)3个月内未服用过包括枸橼酸氯米芬在内的促排卵药物;
(4)输卵管造影检查后证实子宫形态正常,输卵管至少一侧通畅;
(5)治疗后有条件进行随访和彩超检测,受孕后能接受随访者;
(6)自愿接受药物治疗,能按时回访,能按要求进行临床治疗观察者;
(7)既往无严重药物过敏史;
(8)愿意配合临床试验并自愿签署知情同意书。
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Inclusion criteria
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(1) They are 20-40 years old and have fertility requirements;
(2) Syndrome differentiation of kidney depression and ovulation syndrome of Western medicine accord with PCOS standard of the patients;
(3) No ovulation induction drugs including clomiphene citrate were taken within 3 months;
(4) After salpingography, the uterus was normal and at least one side of the fallopian tube was unobstructed;
(5) Those who can accept follow-up and color Doppler ultrasound examination after treatment;
(6) Those who voluntarily receive drug treatment, can return visit on time, and can observe clinical treatment as required;
(7) There was no history of serious drug allergy;
(8) Willing to cooperate with clinical trials and sign informed consent.
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排除标准:
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(1)具有其他不孕因素:卵巢早衰、子宫因素,如性腺发育不全、生殖道畸形、生殖器官器质性病变(子宫腺肌症、子宫肌瘤等)、盆腔炎性疾病;经子宫输卵管造影证实双侧输卵管不通畅者;免疫因素、男方因素;
(2)其他原因导致的与 PCOS 临床和内分泌征象相仿的疾病,如甲状腺功能异常、高泌乳素血症、先天性肾上腺皮质增生、分泌雄激素肿瘤、库欣综合征等;
(3)各种恶性肿瘤;合并严重的心脑血管、肝、肾、造血系统疾病及精神病者;
(4)既往有枸橼酸氯米芬抵抗病史患者;
(5)曾接触致畸的放射线、毒物或药物并处于作用期;
(6)临床资料不全难以诊断者;
(7)未按规定用药依从性不高者,不能定期随访者;
(8)同时参加其他临床研究,影响本研究结果者。
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Exclusion criteria:
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(1) There are other infertility factors: premature ovarian failure, uterine factors, such as gonadal hypoplasia, reproductive tract malformation, organic diseases of reproductive organs (adenomyosis, hysteromyoma, etc.), pelvic inflammatory diseases; hysterosalpingostomy; the factors of immunity and male side were immune factors and male factors;
(2) Other diseases with similar clinical and endocrine signs as PCOS, such as thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, androgen secreting tumor, Cushing's syndrome, etc;
(3) All kinds of malignant tumors, combined with serious cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases and mental illness;
(4) Patients with previous history of clomiphene citrate resistance;
(5) They have been exposed to teratogenic radiation, poison or drugs and are in the active stage;
(6) Patients with incomplete clinical data are difficult to diagnose;
(7) Those who fail to comply with the regulations and are not able to follow up regularly;
(8) Those who participated in other clinical studies and influenced the results of this study.
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研究实施时间:
Study execute time:
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从From
2021-01-13
至To
2023-10-13
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征募观察对象时间:
Recruiting time:
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从From
2021-01-13
至To
2023-01-13
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