Effect of Traditional Chinese Medicine on In Vitro Fertilization (IVF) Success Rates (TCM-P002)

• The proportion of subjects who receive an embryo transfer which results in a live birth. [ Time Frame: Average of 1 year ] [ Designated as safety issue: No ]
  Embryo transfer resulting in Live Birth up to 40 weeks gestation
• 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 ] [ Designated as safety issue: Yes ]

• The proportion of subjects who receive an embryo transfer which results in a live birth. [ Time Frame: Embryo transfer resulting in Live Birth up to 40 weeks gestation ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: Yes ]

• 1. The proportion of subjects who undergo an embryo transfer which results in implantation as evidenced by USS at 7 weeks. [ Time Frame: Average of 4 months ] [ Designated as safety issue: No ]
  At 7 week ultrasound
• 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). [ Time Frame: Average of two months ] [ Designated as safety issue: No ]
  Repeat measures at Screening, Treatment Month and at Embryo Transfer

• 1. The proportion of subjects who undergo an embryo transfer which results in implantation as evidenced by USS at 7 weeks. [ Time Frame: At 7 week ultrasound ] [ Designated as safety issue: No ]
• 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). [ Time Frame: Repeat measures at Screening, Treatment Month and at Embryo Transfer ] [ Designated as safety issue: No ]

The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).

• Primary Female Infertility
• Secondary Female Infertility

• No Intervention: IVF-No Acupuncture
  IVF with no Traditional Chinese Medicine: Acupuncture
• Active Comparator: IVF-Acupuncture
  IVF with Traditional Chinese Medicine: Acupuncture
  Intervention: Other: Traditional Chinese Medicine

Inclusion Criteria:

1. Subject is able to understand and provide consent
2. Subject is female, 21-42 years of age at time of screening and has at least one l ovary
3. Subject BMI is > 18 and < 32
4. Subject is experiencing primary or secondary infertility
5. Subject may receive sperm from donated source
6. Subject's partner has sperm in the ejaculate
7. Subject's serum basal FSH is < 11 IU/L
8. Subject's serum basal estradiol level is between 20-80 pg/mL
9. Subject's TSH level is < 3.0 mv/mL
10. Subject's prolactin level is < 24 ng/mL
11. Subject will agree to limit caffeine intake to one cup (76.5 mL/day) by the time of randomization
12. Subject agrees not to make alterations in diet and lifestyle practices other than those that their Medical Practitioner deems necessary in the best interest of the subject
13. Subject agrees not to participate in any other research opportunities for the duration of the study

Exclusion Criteria:

1. Subject is pursuing sex selection
2. Subject is undergoing treatment with an egg donor
3. Subject experienced more than 2 previous failed cycles
4. Subject is undergoing a heparin or lovenox-based protocol
5. Subject is currently taking herbal therapy (1 week wash-out)
6. Subject is currently taking co-interventions of moxibustion and cupping
7. Subject is exhibiting uterine anomalies (i.e.,bicornuate, unicornuate uterus,)
8. Subject is diagnosed with severe endometriosis defined as endometriomas > 4cm
9. Subject is currently receiving acupuncture therapy (Subject must agree to a 30 day washout period prior to randomization)
10. Subject has history of recurrent spontaneous abortions defined as > 3
11. Subjects with a Beck Depression Inventory (BDI-II) of 29 or higher at screening, indicative of severe depression, will be excluded from the study and referred for further psychological evaluation by our in-house licensed mental health professional.