Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Acupuncture Pre-treatment Combined With Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome
Brief Summary: This is a study protocol for a multicenter, randomized, and controlled trial. In this protocol, we present a randomized controlled trial comparing acupuncture pretreatment followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS women is considered to be one of the major pathophysiological changes of PCOS, leading to anovulatiory infertility. A study has shown that electro-acupuncture could significantly improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS women followed by ovulation induction has not been investigated before. A total of 384 patients enrolled in this study will be randomized into one of two groups. The treatment group: a 16 week acupuncture pretreatment followed by 4 cycles of letrozole and the control group: 4 cycles of letrozole alone. The primary outcome is the live birth rate. We postulate that acupuncture pretreatment followed by letrozole results in a higher live birth rate when compared with letrozole alone.


Options:
A: Arm Label: Pre-treatment acupuncture + letrozole; Type: EXPERIMENTAL; Interventions: Other: Pre-treatment acupuncture, Drug: Letrozole | Arm Label: Letrozole; Type: ACTIVE_COMPARATOR; Interventions: Drug: Letrozole | Intervention Type: OTHER; Name: Pre-treatment acupuncture; Assigned to Arm(s): Pre-treatment acupuncture + letrozole | Intervention Type: DRUG; Name: Letrozole; Assigned to Arm(s): Letrozole, Pre-treatment acupuncture + letrozole
B: Arm Label: Clomiphene citrate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Clomifene citrate | Arm Label: Letrozole; Type: ACTIVE_COMPARATOR; Interventions: Drug: Letrozole | Intervention Type: DRUG; Name: Letrozole; Assigned to Arm(s): Letrozole | Intervention Type: DRUG; Name: Clomifene citrate; Assigned to Arm(s): Clomiphene citrate
C: Arm Label: arm 1:letrozole-pioglitazone -metformin group; Type: ACTIVE_COMPARATOR; Interventions: Drug: induction of ovulation using letrozole-pioglitazone-metformin, Radiation: transvaginal ultrasound, Other: body mass index (BMI) calculation, Other: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone, Other: pretreatment blood urea and serum creatinine, Other: serum estradiol (E2) on day 12, Other: serum progesterone on day 21, Other: blood urea and serum creatinine every month | Arm Label: arm 2: clomiphene citrate-pioglitazone-metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: induction of ovulation using clomiphene citrate-pioglitazone-metformin, Radiation: transvaginal ultrasound, Other: body mass index (BMI) calculation, Other: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone, Other: pretreatment blood urea and serum creatinine, Other: serum estradiol (E2) on day 12, Other: serum progesterone on day 21, Other: blood urea and serum creatinine every month | Intervention Type: DRUG; Name: induction of ovulation using letrozole-pioglitazone-metformin; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group | Intervention Type: DRUG; Name: induction of ovulation using clomiphene citrate-pioglitazone-metformin; Assigned to Arm(s): arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: RADIATION; Name: transvaginal ultrasound; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: body mass index (BMI) calculation; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: pretreatment blood urea and serum creatinine; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: serum estradiol (E2) on day 12; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: serum progesterone on day 21; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: blood urea and serum creatinine every month; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin
D: Arm Label: Graceful Lifestyle Changes & MYO; Type: EXPERIMENTAL; Interventions: Behavioral: Graceful Lifestyle Changes, Dietary Supplement: Myo-inositol | Arm Label: Graceful Lifestyle Changes; Type: EXPERIMENTAL; Interventions: Behavioral: Graceful Lifestyle Changes | Arm Label: Letrozole & MYO; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Myo-inositol, Drug: Letrozole | Arm Label: Letrozole; Type: PLACEBO_COMPARATOR; Interventions: Drug: Letrozole | Intervention Type: BEHAVIORAL; Name: Graceful Lifestyle Changes; Assigned to Arm(s): Graceful Lifestyle Changes, Graceful Lifestyle Changes & MYO | Intervention Type: DIETARY_SUPPLEMENT; Name: Myo-inositol; Assigned to Arm(s): Graceful Lifestyle Changes & MYO, Letrozole & MYO | Intervention Type: DRUG; Name: Letrozole; Assigned to Arm(s): Letrozole, Letrozole & MYO

Answer: A