The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
8
Active arm will receive Acupuncture with their IVF cycle.
The proportion of subjects who receive an embryo transfer which results in a live birth.
Embryo transfer resulting in Live Birth up to 40 weeks gestation
Time frame: Average of 1 year
The proportion of subjects in the active treatment group experiencing no SAE's attributable to ACU.
Time frame: Overall to be collected at interim analysis of 138 subjects and at study completion of 276 patients
1. The proportion of subjects who undergo an embryo transfer which results in implantation as evidenced by USS at 7 weeks.
At 7 week ultrasound
Time frame: Average of 4 months
Effect of the IVF/ICSI treatment on quality of life and psychological factors assessed with the Fertility Quality of Life Questionnaire (FertiQoL 2008) and the Spielberger State Trait Anxiety Inventory (STAI).
Repeat measures at Screening, Treatment Month and at Embryo Transfer
Time frame: Average of two months
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