Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome
Condition: Pregnancy; Polycystic Ovary Syndrome; Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional

Summary: 
      The objectives of the present trial are to test the following three hypotheses in anovulatory
      women with PCOS:

        1. Acupuncture protocol 1 plus CC (Arm A) is more likely to result in live birth than
           acupuncture protocol 2 combined with CC (Arm B),

        2. Acupuncture protocol 2 plus CC (Arm B) is more likely to result in live birth than
           acupuncture protocol 1 plus placebo (Arm C),

        3. Acupuncture protocol 1 plus placebo (Arm C) is more likely to result in live birth than
           acupuncture protocol 2 plus placebo (Arm D).
    

Detailed description: 
      This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Chinese
      women with PCOS.

      Primary outcomes:

      - Live birth rate

      Secondary outcomes:

        -  Ovulation rate

        -  Ongoing pregnancy rate

        -  Multiple pregnancy rate

        -  Miscarriage rate

        -  Hormonal profile

        -  Metabolic profile

        -  Side effect profile
    

Intervention name(s): Acupuncture treatment 1; Acupuncture treatment 2; CC; CC placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV3, CV 6, and ST 29 bilaterally，SP 6 and SP 9 bilaterally. Needles will also be placed in LI bilaterally and GV 20. CV 3, CV 6, ST 29, SP 6, and SP 9 will be connected to and electrical stimulator and stimulated with low-frequency EA of 2Hz, 0.3 ms.; Needles will be inserted to a depth of <5 mm, one in each shoulder and on in each upper arm at non-acupuncture points. Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture treatment 1. No manual stimulation of the needles will be performed.; CC 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.; CC placebo 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC Placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infertility; Polycystic Ovary Syndrome; Clomiphene citrate; Acupuncture