Objective To systematically review the methodological quality of guidelines concerning infertility, so as to provide references for clinical practice. Methods Guidelines concerning infertility were electronically retrieved (from inception to Feb. 2013) in PubMed, EMbase, CBM, WanFang Data, CNKI, GIN guideline database guideline development websites (including NGC, NICE, SIGN, NZGG, SOGC, etc.), and medical associtation websites (including IFFS, FIGO, ESHRE, NFOG, RCOG, ASRM, ACOG, etc.). We also searched Chinese guideline websites including the website of the National Health and Family Planning Commission of People’s Republic of China, CGC (China Guideline Clearinghouse), and CPGN (Clinical Practice Guideline Net). Two reviews independently screened literature according to the inclusion and exclusion criteria, and assessed the quality of guideline development and reporting using the Appraisal of Guidelines for Research and Evaluation (AGREE II). Results a) A total of 16 guidelines concerning infertility were included, with development time ranging from 1998 to 2012. Among 16 guidelines, 10 guidelines were made by the USA, 3 by Britan, 1 by the Europe, and 1 by America and Europe. b) The scores of guidelines according to the domains of AGREE II decreased from “Clarity of presentations, scope and purpose”, “Participants”, “Applicability”, “Rigour of development”, and “Editorial independence”. 16 guidelines were generally low in quality. The levels of recommendations were Level A (5 guidelines), Level B (8 guidelines), and Level C (3 guidelines). c) Four evidence-based guidelines scored the top three in the domain of “Rigour of development”. d) The recommendations of different guidelines were fairly the same. e) No guidelines on infertility have been developed in China. Conclusion a) The guidelines on infertility should be improved in “Rigour of development” and “Applicability” in future. Conficts of interest should be addressed. b) Guidelines are recommended to be developed on the basis of the methods of evidence-based medicine, and best evidence is recommended. c) National organizations such as ASRM should be established in China, so as to develop biomedicine and TCM guidelines based on evidence and regulate the treatment. d) For the general assessment of guidelines, AGREE II should offer threshold criteria of suggestion.
Objective To investigate infertile inpatients hospitalized in Pingjin Hospital in Tianjin from 2008 to 2010, so as to provide baseline data for further research. Methods According to diagnosis criteria of WHO, we collected demographical characteristics, disease cause and cost constitution of infertility inpatients hospitalized in Pingjin Hospital in Tianjin from 2008 to 2010. The data of each patient were input into ACCESS database and SPSS 13.0 was used for statistical analysis. Results a) From 2008 to 2010, there were 1 452 infertile patients from 33 different areas of mainland China, 79.7% of which was from the north of China. b) The mean age was 31.2±4.3 years old. The percentage of patients aged 30 to 34 years accounted for the most (40.3%). Mental laborers (23.3%) were more than physical laborers (7.2%). 36.7% of patients received education from universities and 83.1% of patients had family income ranging from 20,000 yuan to 190,000 yuan. c) The mean age of the first sexual activity was 21.4±2.9 years old. 53.7% of patients had only one sexual partner and most couples had sexual activities twice every week. The mean age of husbands was 32.9±5.5 years old with the highest percentage of 30 to 35 years old (39.2%). The percent of intellectual work of husband was the highest (35.9%). 64.9% of patients had normal semen analysis results and 23.0% never took related examination. d) 29.9% of patients was primary infertility and 70.1% was secondary infertility, of which 57.6% had either induced or medical abortion. The mean duration of infertility was 5.2±3.5 years (range 1 to 21 year). e) 76.3% of infertile patients had pelvic adhesion and 88.6% suffered from tubal disease. Among the tubal infertile patients, 23.6% had uterine disease, 5.2% had ovarian disease, 5.0% had endometriosis, 6.7% had multiple problems, and 4.8% had unexplained infertility. In patients with tubal infertility, the incidence of distal fimbria atresia (45.8%) was higher than that of proximal block (32.9%). 24.7% of patients with fimbria atresia had hydrosalpinx and among of them, 21.1% had no hydrosalpinx. 15.2% had congenital tubal defects. f) The average hospital stay was 10.5 days and the cost was 14 253.3 yuan per person. The percentage of material cost was 29.1% and that of drugs was 18.2%. Conclusion a) The total number of infertile inpatients was 1 452 in gynecology department of Pingjin Hospital of Tianjin from 2008 to 2010. 79.7% of patient was from North China. Most of them were 30 to 34 years old and 44.3% had no job. The percentage of patients had university education and that of low-middle family income was the highest. Sexual activity was relatively traditional. Most husbands were 30 to 35 years old and intellectual workers, and 23.0% of them had never taken an examination of semen analysis. More patients were secondary infertile, and the duration of infertility was 1 to 21 years. b) 76.3% of patients had pelvic adhesion and 88.6% had tubal disease. The incidence of distal tubal fimbria atresia was higher than proximal tubal occlusion. c) The average hospital stay was 10.5 days and the cost was 14 253.3 yuan per person which was further lower than each cycle cost of assisted reproductive technology. The overall costs included materials and drugs (47.3%), which were mainly at patients’ own expense.
Objective To investigate the application of hysteroscopy in pathological changes of infertility uterus. Methods The clinical data of 226 cases of infertility females receiving hysteroscopy from January 2007 to June 2009 in Sichuan Provincial Hospital for Women and Children were retrospectively analyzed. Results In 226 cases, hysteroscopic examination identified 147 cases of intrauterine diseases (65.04%), including 56 cases of intrauterine adhesion (24.78%), 32 cases of endometritis (14.16%), 27 cases of endometrial polyps (11.94%), 15 cases of uterine malformation (6.64%), 9 cases of submucous myoma (3.98%), 3 cases of endometrial tuberculosis (1.33%), 3 cases of uterus cavity narrow (1.33%), 2 cases of cervical internal relaxation (0.88%). No postoperative complications occurred, except for a small amount of vaginal bleeding. Conclusion For the diagnosis of the pathological changes in uterus, hysteroscopy is a direct and accurate method with less operative duration, less trauma, less pain, quick recovery, no complications, and no necessity for hospitalization. It is worth to be popularized.
现有治疗排卵功能障碍性不孕的临床证据如下,①克罗米酚.1个系统评价结果表明,对不规则排卵妇女,克罗米酚与安慰剂相比,明显提高了妊娠率.另外4个克罗米酚和他莫昔芬的研究表明,这两种药物对排卵率和妊娠率的影响无统计学差异.1个随机对照试验(RCT)表明,6个月疗程的克罗米酚加二甲双胍比单用克罗米酚可明显提高妊娠率.②环芬尼:1个RCT表明,环芬尼与安慰剂相比,对妊娠率的影响无统计学差异.③促性腺激素(HMG):1个系统评价表明,HMG治疗与尿促卵泡素(urofollitropin)治疗相比,两者妊娠率无统计学差异.2个RCT表明,重组的促滤泡素和尿促卵泡素治疗相比,两者的持续妊娠率和活产率无统计学差异.以往的研究发现,虽然仅限于那些没有配合使用GnRHa的妇女,但HMG与尿促卵泡素治疗相比,发生卵巢过度刺激综合征的危险性较小.观察性研究证据表明,促性腺激素使用可能使卵巢非侵袭性肿瘤发病及多胎妊娠发生增加.④腹腔镜下卵巢打孔:1个系统评价和其后的1个小样本RCT表明,促性腺激素治疗和卵巢打孔治疗相比,对妊娠率影响的无统计学差异,但卵巢打孔术后多胎妊娠的发生率明显较低.促性腺激素脉冲疗法:有1个系统评价结果,但没有发现促性腺激素脉冲疗法有效.
Objective To evaluate the effectiveness and safety of aromatase inhibitors in ovulation induction for women with unexplained infertility. Methods The databases such as CNKI (1994 to June 2011), WanFang Data (1982 to June 2011), PubMed (1966 to June 2011) and The Cochrane Library (Issue 6, 2011) were searched to collect randomized controlled trials (RCTs) and quasi-randomized controlled trials (quasi-RCTs) for the comparison between aromatase inhibitors (AIs) and clomiphene citrate (CC). The quality of the retrieved trials was critically appraised and meta-analyses were conducted using RevMan 5.0.1 software. Results Nine studies were included; all of them were published in English. The results of meta-analyses showed there were no significant differences between AIs and CC in the pregnancy rate (RR=1.02, 95%CI 0.71 to 1.47), miscarriage rate (RR=1.00 95%CI 0.61 to 1.63), multiple pregnancy rate (RD= –0.02, 95%CI –0.07 to 0.03), and incidence rate of adverse events (RD=0.00, 95%CI –0.01 to 0.01); there were still no significant differences between the AIs+gonadotropin (Gn) group and the CC+Gn group in the pregnancy rate (RR=0.98, 95%CI 0.68 to 1.42), miscarriage rate (RR=1.23, 95%CI 0.70 to 2.15), multiple pregnancy rate (RD=0.00, 95%CI –0.10 to 0.10), and incidence rate of adverse events (RD=0.00, 95%CI –0.10 to 0.01). Conclusion Whether aromatase inhibitors can replace clomiphene citrate in ovulation induction for women with unexplained infertility is still an issue that has to be identified by performing well-designed large scale RCTs with longer follow-up duration.
①关于药物引起的卵巢抑制:1篇系统评价发现,使用卵巢抑制药治疗子宫内膜异位症与安慰剂或达那唑相比,妊娠率无明显差异.该评价还发现,卵巢抑制药引起的不良反应包括体重增加、潮热和骨质疏松症,达那唑可能引起剂量相关的体重增加和雄激素样作用. ②宫腔内人工授精+促性腺激素:1个RCT发现,宫腔内人工授精+促性腺激素治疗与不治疗相比,可明显提高活产率.第2个RCT发现,期待疗法与宫腔内人工授精+垂体降调节+促性腺激素治疗后的分娩率无明显差异.第3个RCT发现,宫腔内人工授精+促性腺激素治疗与单用宫腔内人工授精相比,仅明显提高妊娠率. ③体外受精:我们没有找到关于子宫内膜异位症引起不孕妇女接受受精体外治疗的RCT. ④手术治疗:两个比较腹腔镜手术与诊断性腹腔镜的RCT发现,在妊娠率和活产率方面结论不一.
Objective To assess the effectiveness and safety of traditional Chinese medicinal herbs for subfertility. Method Databases used including MEDLINE, EMBASE, CBM and the Cochrane Controlled Trial Register (CCTR). Potentially related trials in reference lists of studies were hand searched. Published RCTs in any languages and length whether they were blind or unblind, were included. Treatments were Chinese medicinal herbs (single or compound), and controls were placebo, standard medical intervention, or no intervention. Data were extracted independently by two reviewers and analyzed with Revman 4.2 softeware. Results 7 randomized trials, including 1 042 patients met inclusion criteria. Methodological quality of all trials was poor. Chinese medicinal herbs were effective compared with routine antibiotics [RR 1.49, 95％CI (1.37 to1.62), Plt;0.000 01] and resulted in higher pregnancy rate [RR 1.46, 95%CI (1.09 to,1.96), P=0.01]. There were no adverse events reported in treatment group. Conclusions Some Chinese medicinal herbs may be effective for subfertility. However, the evidence is too weak to draw a conclusion. More strictly designed, randomized, double-blind, placebo-controlled trials are required.
Objective To assess the effectiveness and safety of Chinese medicinal herbs for female immune-caused subfertility. Methods Databases included: MEDLINE (1966-2002.2), EMBASE (1984-2002.2), CBM (1978-2002.2) and Cochrane Controlled Trial Register, CCTR (Issue 1, 2002). Reference lists of trials were handsearched. Published randomized controlled trials (RCTs) whether blind or unblind, any languages and length of follow up were included. Treatments included Chinese medicinal herbs (single or compound). Controls were placebo and western medicine, or no intervention. Data were extracted independently by two reviewers and analyzed with Revman 4.2. Results Six RCTs were included, all of which were poor in methodological quality. Because of different therapies in the treatment and control groups, we did not perform meta-analysis. The No.1 anti-immune tablet was more effective than corticosteroid plus condom during intercourse both in the pregnancy rate (RR 3.75, 95%CI 1.61 to 8.75, P=0.002) and AsAb negative rate (RR 1.66, 95%CI 1.23 to 2.22, P=0.000 8). Bushen Xiezhuo Soup was more effective than antibiotic in the pregnancy rate (RR 2.97, 95%CI 1.60 to 5.50, P=0.000 6) and antisperm antibody (AsAb) negative rate (RR 2.33, 95%CI 1.54 to 3.54, Plt;0.000 1)。Zhenqi Zhuanyin Soup was as effective as IUI in pregnancy rate (RR 1.80, 95%CI 0.58 to 5.60, P＝0.31) but more effective than IUI in AsAb negative conversion rate (RR 9.61, 95%CI 3.22 to 28.67, Plt;0.000 1), Zhenqi Zhuanyin Soup combined with IUI was more effective than IUI in pregnancy rate (RR 3.60, 95%CI 1.32 to 9.85,P=0.01) and AsAb negative rate (RR 8.92, 95%CI 2.98 to 26.75, Plt;0.000 1). Conclusions Some Chinese medicinal herbs may work well in subfertility treatment. However, the evidence is too weak to draw a conclusion for there are deficiencies in strict randomization, blinding and follow-up.More strictly designed, randomized, double-blind, placebo-controlled trials are required.
【摘要】 目的 观察腹腔镜手术联合孕三烯酮治疗子宫内膜异位症合并不孕的疗效及不同评分系统对妊娠结局的预测价值。 方法 回顾性分析2004年1月-2006年12月收治的97例子宫内膜异位症合并不孕患者的临床病理资料，统计其术后妊娠率及活产率。 结果 术后1年内与1~2年的妊娠率与活产率比较，差异均无统计学意义（Pgt;0.05）。根据美国生育协会1985年修订的子宫内膜异位症分期标准（r-AFS）进行分期，各期患者术后妊娠率差异无统计学意义（Pgt;0.05）；但随着分期升高，活产率逐渐下降（Plt;0.05）。子宫内膜异位症生育指数（EFI）评分越高，其妊娠率和活产率也越高（Plt;0.05）。 结论 子宫内膜异位症患者腹腔镜手术后联用孕三烯酮可能会提高远期妊娠率。r-AFS分期对妊娠结局的预测有一定局限性，而EFI具有较好的预测性。【Abstract】 Objective To evaluate the therapeutic effectiveness of laparoscopic surgery combined with gestrinone treatment in the infertile women with endometriosis (EM), and the value of different score systems to predict gestational outcome. Methods We retrospectively analyzed the clinical data of 97 infertile women with EM who were treated in our hospital from January 2004 to December 2006, and collected their pregnancy rate (PR) and live birth rate (LBR) after operation. Results There was no significant difference of PR and LBR within the 1st year and between the 1st and the 2nd year (Pgt;0.05). There was no significant difference of PR among women of various stages of EM based on the 1985 edition of risk stratification for patients with EM put forward by American Fertility Society (r-AFS) (Pgt;0.05), but the LBR decreased with the raising of the stages (Plt;0.05). The endometriosis fertility index (EFI) was positively correlated with PR and LBR (Plt;0.05). Conclusion Laparoscopic surgery combined with gestrinone may increase the long-term pregnancy rate of women with EM. R-AFS classification is limited in predicting the gestational outcome of women with EM, while EFI achieves a better result.