IRCT201011275181N4.

Trial name or title	Effects of acupuncture on outcome of in vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) in women with polycystic ovarian ‐
Methods	Parallel design, triple blind, randomised controlled trial
Participants	Inclusion criteria: women with the diagnosis of PCO (Rotterdam criteria) admitted to the clinic for IVF or ICSI treatments of infertility
Interventions	Intervention group 1: acupuncture based on Traditional Chinese Medicine, 5 sessions of thirty minutes. Intervention 2: Control group: (placebo) the same needles are used in 5 sessions of thirty minutes
Outcomes	Primary outcomes: Embryo quality. Timepoint: 2 days after embryo transfer. Method of measurement: diagnosed by Embryologist and with embryological criteria. Oocyte fertilisation rate. Timepoint: first day after embryo transfer. Method of measurement: diagnosed by embryologist and with embryological criteria Oocyte metaphase 2. Timepoint: before and after embryo transfer. Method of measurement: diagnosed by embryologist and with embryological criteria Secondary outcomes: Biochemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: B‐hCG Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: sac observed in vaginal sonography Miscarriage. Timepoint: <12 weeks after embryo transfer. Method of measurement: vaginal sonography Take home baby. Timepoint: 9 months after embryo transfer. Method of measurement: Delivery
Starting date	Registration 13/04/2011
Contact information	Rashidi Batool Address: Tehran University of Medical Sciences, Valieasr Hospital and Imam Khomeini Hospital Tehran Islamic Republic of Iran
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