A Clinical Study On Bushen Culuan Granule In Treating Infertility Patients With Diminished Ovarian Reserve

1 ObjectiveTo observe the efficacy and safety of Bushen Culuan Granule in the treatment of female infertility due to DOR in a double-blind,randomized controlled trial,and as a result to provide scientific basis for further clinical application.2 Methods30 patients with infertility due to DOR of kidney deficiency and blood stasis type were selected according to the inclusive and exclusive criteria,and was randomly divided into 2 groups:Therapy Group(Bushen Culuan Granule and placebo of clomiphene)and the Control Group(clomiphene and placebo of Bushen Culuan Granule).One to two courses of treatment were observed,and the changes of total efficiency,ovulation rate,pregnancy rate,serum hormone index,ultrasound index,and TCM symptom score after treatment were analyzed and evaluated for safety.The patients were followed up for 6-12 months to observe the long-term pregnancy outcome.3 Results(1)The total effective rate was 86.67%in the therapy group and 66.67%in the control group.The total effective rate of Bushen Culuan Granule was comparable to that of clomiphene.(2)The ovulation rate was 61.90%in therapy group and 65.52%in the control group.The ovulation induction effect of Bushen Culuan Granule was comparable to that of clomiphene.(3)The pregnancy rate was 20.00%in therapy group and 6.67%in the control group.Bushen Culuan Granule was superior to Clomiphene in increasing the pregnancy rate.(4)Bushen Culuan Granule can significantly reduce serum FSH,increase serum E2 level and increase AMH content,and the effect is better than that of clomiphene;it is comparable to clomiphene in regulating LH and AFC.(5)Bushen Culuan Granule can improve the symptoms of kidney deficiency and blood stasis in patients,especially in the treatment of symptoms such as low menstrual flow,dizziness,and tinnitus,poor menstruation,blood clots in menstruation,tingling in the lower abdomen,aggravated sexual intercourse,and the total score of TCM symptoms.It is more significant than clomiphene in terms of improving menstrual arrest,late menstruation,weak waist and knees,loss of libido,mental fatigue,frequent urination,frequent urination at night,multi-colored and dark menstrual flow,and abdominal pain during menstruation.(6)The safety evaluation was grade 1.Both Bushen Culuan Granule and Clomiphene were safe and had no toxic side effects.(7)There were 2 cases of pregnancy and no cases of miscarriage in the therapy group during the follow-up period;1 case of pregnancy and 1 case of miscarriage in the control group during the follow-up period.4 ConclusionBushen Culuan Granule can significantly improve the pregnancy rate of patients with infertility caused by DOR.It also has obvious curative effects in terms of total efficiency and ovulation rate.It can reduce FSH,increase E2,increase AMH,and increase the number of AFC,which can improve the symptoms of traditional Chinese medicine.The curative effect of Bushen Culuan Granule is more advantageous.There were no adverse reactions during the treatment,and the safety evaluation was grade 1,which is worthy of clinical application.