Primary Female Infertility Clinical Trial
— TCM-P002Official title:
A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates
| Verified date | October 2015 |
| Source | Pacific Fertility Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 21 Years to 42 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Pacific Fertility Center |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | Yes | |
| Secondary | 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 | No |
| Secondary | 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 | Average of two months | No |