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Enrollment rate slower than anticipated.
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The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVF-No Acupuncture | No Intervention | IVF with no Traditional Chinese Medicine: Acupuncture | |
| IVF-Acupuncture | Active Comparator | IVF with Traditional Chinese Medicine: Acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Chinese Medicine | Other | Active arm will receive Acupuncture with their IVF cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Average of 1 year |
| The proportion of subjects in the active treatment group experiencing no SAE's attributable to ACU. | Overall to be collected at interim analysis of 138 subjects and at study completion of 276 patients |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eldon Schriock, MD | Pacific Fertility Center | Principal Investigator |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Repeat measures at Screening, Treatment Month and at Embryo Transfer |
| Average of two months |