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

This study has been terminated.
(Enrollment rate slower than anticipated.)
Sponsor:
Information provided by (Responsible Party):
Eldon Schriock, MD, Pacific Fertility Center
ClinicalTrials.gov Identifier:
NCT01331395
First received: April 4, 2011
Last updated: December 7, 2012
Last verified: December 2012

April 4, 2011
December 7, 2012
June 2011
June 2013   (final data collection date for primary outcome measure)
  • 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 ]
Complete list of historical versions of study NCT01331395 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
 
Effect of Traditional Chinese Medicine on In Vitro Fertilization (IVF) Success Rates
A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Primary Female Infertility
  • Secondary Female Infertility
Other: Traditional Chinese Medicine
Active arm will receive Acupuncture with their IVF cycle.
Other Name: Acupuncture
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Female
21 Years to 42 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01331395
2010.097-1 (Esch)
No
Eldon Schriock, MD, Pacific Fertility Center
Pacific Fertility Center
Not Provided
Principal Investigator: Eldon Schriock, MD Pacific Fertility Center
Pacific Fertility Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP