| ObjectiveTo explore and further develop and perfect the scientific basis and the reference index of clinical evaluation of follicular quality, clinical diagnosis and treatment and curative effect evaluation of follicular dysplasia; Uncover and objectively evaluate the mechanism of action and clinical curative effect on controlling from the overall, promoting the normal development,maturation and ovulation of follicle and improving the clinical pregnancy rate/cycle pregnancy rate of the Chinese medicine, in order to provide the scientific basis for further experimental and clinical research and application and promotion.Methods1.The research has summarized the academic thought of professor You Zhao-Ling on follicular development, including the Chinese medicine theory origin, the understanding of essence and the time-space characteristic of follicle development; the lesion connotation, the clinical manifestation and classification and the new method of diagnosis and treatment of follicular dysplasia; as well as the time-space abnormal performance and basic therapeutic schedule about PCOS infertility’s follicular dysplasia. 2. Follow the principles and methods of clinical randomized controlled trials, the patients with PCOS infertility meeting inclusion criteria were randomly assigned for the treatment group (30cases) and the control group (30cases). The treatment group used the Chinese medicine periodic therapy of tonifying kidney and regulating menstrual cycle,adjusting follicle and promoting pregnancy combined with clomiphene citrate. The control group used clomiphene citrate to treat alone.The patients of the two groups were observed before and after treatment with Chinese medicine clinical syndrome of kidney deficiency, hair distribution, five rounds, thenar eminence, shape,basal body temperature and so on,as well as determined serum endocrine hormone levels, follicular development and ovulation, endometrial thickness and type,ovarian volume and other related indexes. The therapeutic effect indexes are compared itself before and after treatment and contrasted between groups after treatment, using SPSS17.0statistical software to make statistical analysis.Results1. General situation:the treatment group improved the PCOS infertility patients’ Chinese medicine clinical syndrome of kidney deficiency, five rounds and clinical manifestation of androgen such as hairiness and obesity, established hiphasic basal body temperature, and restored menstrual cycle and ovulation, which curative effect is significant(P<0.01); to some extent the control group improved the Chinese medicine clinical syndrome of kidney deficiency and hairiness(P<0.05), but the differences of BMI and five rounds after the treatment had no statistical significance (P>0.05); in addition, curative effect of the treatment group in improving the Chinese medicine clinical syndrome of kidney deficiency and five rounds is better than that of the control group (P<0.01).2. Endocrine hormone level:the decline levels of serum LHã€Tã€LH/FSH in the treatment group after treatment were statistically significant (P<0.01); after treatment, the rising levels of serum E2and P in the treatment group were statistically significant(P<0.05). In the control group after treatment,the serum LH and LH/FSH reduced, which was statistically significant (P<0.05); but the differences of serum E2, P and T levels had no statistical significance (P>0.05). After the treatment, comparison of the decline levels of LHã€T and LH/FSH ratio between the two groups was statistically significant(P<0.05). The treatment group had weak estrogen-like effect which can improve the patients’ serum E2and P levels.But there was no statistically significant difference compared between the two groups (P>0.05).Compared itself before and after treatment and contrasted between two groups after treatment of serum FSH and PRL levels, there were no statistically significant difference (P>0.05)3. The state of endometrial receptivity:the pregnancy rates of endometria with different thickness and type are different. Between8and12mm, the pregnancy rate with the increase of endometrial thickness was on the rise.Among them, there were Most pregnancy cases between9and11mm. In three types of endometrium, only endometria of type A and type B had the ability to conceive and the pregnancy rate of endometria of type A was highest. After the treatment, compared of endometrial thickness,type and the proportion of A+B type in the day of injection of HCG between the two groups, the differences were statistically significant(P<0.01).4. Ovarian local microenvironment:the treatment group could significantly improve patients with thenar eminence situation, which was statistically significant(P<0.01).But there was no statistical difference in the control group (P>0.05). The curative effect of the treatment group is significantly better than that of the control group(P<0.01). Although ovarian volume had a tendency to shrink in the two groups,compared itself before and after treatment and contrasted between two groups after treatment,there was no statistical difference (P>0.05)5. Follicular development and ovulation:the pregnancy rates with different size and shape of ovulatory follicle are different. Tow diameter difference of follicle is inversely proportional to the pregnancy rate. between0and1mm, the pregnancy rates are highest; greater than or equal to3mm, the pregnancy rate was0. Between18to23mm of follicle maximum diameter,the pregnancy rate with the increase of maximum diameter was on the rise. Among them, between22and23mm the pregnancy rate was highest and between20to22mm, the pregnancy cases were most. greater than or equal to24mm, the pregnancy rate is0. After the treatment, compared of follicle maximum diameter, the shortest diameter, two diameter difference and ovulation between two groups, the curative effect of the treatment group in improving size and shape of ovulatory follicle, making it close to the conception of best and improving cycle ovulation rate was significantly better than that of the control group(P<0.01). 6. The total curative effect and pregnancy rate:the total effective rate of the treatment group was93.33%.The clinical pregnancy rate was30%and the cycle pregnancy rate was11.76%.In the control group the total effective rate was64.29%, the clinical pregnancy rate was14.3%and the cycle pregnancy rate was4.94%. The difference of total curative effect between two groups was statistically significant(P<0.01). The clinical pregnancy rate of the treatment group is2.10times of the control group and the cycle pregnancy rate of the treatment group is2.38times of the control group. After the treatment, the comparison of pregnancy between two groups was not statistically significant (P>0.05).Conclusion1.Because of controlled spatially and temporally by reproductive axis that kidney-menstruation-Chong and Ren-uterus,follicular development has time-space characteristic,namely the time synchronization and the specificity of space transformation.According to the abnormal performance of follicle development in terms of time-space, follicular dysplasia will be segmented into eight categories and three types, which can be used as the scientific basis and the reference index of clinical evaluation of follicular quality, clinical diagnosis and treatment and curative effect evaluation of follicular dysplasia.2.The abnormal performance of PCOS infertility’s follicular dysplasia in time-space aspect is multiple follicles, slow growth, flat follicles, poor quality and out of sync with endometrial hyperplasia to see more.PCOS â… and â…¡ are in the majority.Irregular menstruation more see menstrual cycle delay or oligomenorrhea,along with short luteal phase,inadequate luteal function and incompatibility in ovary,follicle and endometrium.The nature of PCOS infertility is follicular dysplasia in aspect of time-space because of ovarian dysfunction. The key point of treatment of Chinese medicine is adjusting kidney in the follicular phase, coordinating ovary,follicle and endometrium in view of the abnormal performance of follicular dysplasia in time-space aspect and improving negative effects and side effects of clomiphene citrate. Its curative effect in promoting the normal development,maturation and ovulation of follicle and improving the endometrial implantation environment is significantly better than pure clomiphene citrate for treatment.3. The treatment group used the Chinese medicine periodic therapy of tonifying kidney and regulating menstrual cycle,adjusting follicle and promoting pregnancy combined with clomiphene citrate.It re-established regulation mechanism of reproductive axis in aspect of time-space, restored ovarian cycle and reproductive endocrine function, relieved the Chinese medicine clinical syndrome of kidney deficiency, improved the ovarian local microenvironment, adjusted the follicle dysplasia in aspects of morphology, size, number and location and improved the quality of ovum and endometrial receptivity. Thus it promotes the normal development,maturation and ovulation of follicle, ultimately improving the embryo implantation rate and clinical pregnancy rate. The clinical curative effect is remarkable. |