| Background of theoryFollicular Maldevelopment (FM) is a symptom that the size and function of ovarian follicle can not up to scratch in the later follicular period. Then it will run to follicular atresia,LUFS or ovulation with low luteal function which would result in infertility. The incidence of FM in infertile women was 27.0%, and it will repeated emergence in different periods of one woman as repetitive rate reach up to 63.8%. The treatment of western medicine is mainly to develop ovarian follicle to maturation via drug. And then to form the normal menstrual cycle or to have conceive, but such drugs might cause that endometrial and follicular development are not synchronized, which lead to high ovulation rate and low pregnancy rate. Chinese traditional medicine treatment of follicular maldevelopment has a unique effect and advantages. Chinese medicine consider follicular development mainly related to kidney, Chong,Ren and systemic Qi and blood, its treatment-based is Chinese herbs for tonifying kidney, and channels and collaterals is the road of Qi and blood. Chong Ren and Du Channel is closely related to menstruation and pregnancy. Professor Li Liyun have proposed the thought that the insufficiency of Chong Ren and Du Channel can affect normal follicular growth and ovulation. She have carried out the clinical treatment of Follicular Maldevelopment by tapping Chong Ren and Du Channel With Plum-Blossom Needle, which have significant effect moreover, its convenience,security and other advantages are favor by many patients. ObjectivesIn this study all patients with FM were divided into two groups: Plum-Blossom Needle and CC/HCG randomly. To look for follicular diameter, endometrial thickness and morphology, ovarian artery resistance index and pulsatility index changes in ovarian artery blood flow by transvaginal color Doppler ultrasound in patients with different groups, and to observe the growth rate of follicles and endometrium dynamicly. Meanwhile to determine and analyze the FSH,LH,E2 and other related reproductive endocrine changes and the level difference between the groups will be compared. On the basis of comparison of clinical efficacy, we will probe the possible mechanism of Plum-Blossom Needle treatment of FM, to explore a safe,convenient,noninvasive and effective method and as scientific basis of clinical promotion.MethodsIn this study, all patients with FM were divided into the Plum-Blossom Needle treatment and CC/HCG treatment randomly by respecting DME principles and methods via randomized controlled trials. Traditional Chinese medicine in the kidney were taken as primary treatment, and the follicular growth phase were taken Plum-Blossom Needle treatment or CC/HCG treatment, to observe the targets and the clinical efficacy. The relevant data would be input SPSS17.0 to establish a database and be analyzed statistically.ResultThe total efficiency of Group Plum-blossom needle was 88.6%, as Ground Western medicine was 63.6%, and the total effective rate between the two groups was significant difference (P<0.05). Group Plum-blossom needle's ovulation rate is 94.29%, which higher than Ground Western medicine's 75.76%. the difference is statistically significant (P<0.05). The rate of pregnancy was 8.6% in Plum-blossom needle, and 6.1% in Western medicine. there was no significant difference (P>0.05). The average diameter of the largest follicle after this special treatment were 18.499±3.260mm and 17.579±6.315mm. Both the two groups were greater than their average diameter of the largest follicles before treatment, and there was signi-ficant difference (P<0.05). After special treatment there was no significant difference between the two groups'follicle size (P>0.05). There was significant difference of the Basal Body Temperature (BBT) between the two groups, for Group Plum-blossom needle's rate of biphasic BBT was 91.43% and Ground Western medicine was 66.67%(P<0.05). Excluding pregnancy cycles, average number of days with high temperature in biphasic BBT cycles was 13.833±1.392 in Group Plum-blossom needle, which was no significant difference with Ground Western medicine's 13.250±2.245 (P>0.05). There was significant difference of Cervical Score (CS) between the two groups, for Group Plum-blossom needle's average score was 11.057±1.494 and Ground Western medicine was 9.364±2.044 (P<0.05). There was significant difference in endometrial thickness and morphology around ovulation (P<0.05). The average endometrial thickness of Group Plum-blossom needle was 10.486±1.976mm, and there are 77.1% cycles had a trilaminar endometrium; the average endometrial thickness of Group CC/HCG was 8.788±2.355mm, and there are 54.5% cycles had a trilaminar endometrium. Both resistive index (RI) and pulsatility index (PI) in Group Plum-blossom needle were lower than Group CC/HCG, which (P<0.05). S/D value between the two groups were no significant difference(P>0.05). Serum sex hormone levels were no significant difference between the two groups(P>0.05).ConclusionPlum-blossom needle have been acted on Chong Ren and Du Channel,ovarian, uterine and other specific acupuncture points, with the motivation of improving ovarian artery blood flow of FM patients, and reducing ovulation side of the PI, RI values, improving the ovarian function and follicle quality, promoting follicle growth, increasing ovulation rate of mature follicle. The efficacy of Plum-blossom needle treatment is stronger than CC/HCG treatment. Endometrial thickness and endometrial morphology of Plum-blossom needle group were better than CC/HCG group, for Plum-blossom needle treatment could avoid the shortage that follicular growth and endometrial growth couldn't be synchronized which often happen in CC/HCG cycles. However, the pregnancy rate between the two groups showed no statistical significance.
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