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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
History of Changes
  Purpose

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


Condition Intervention
Primary Female Infertility
Secondary Female Infertility
 Other: Traditional Chinese Medicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pacific Fertility Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 8
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: IVF-No Acupuncture
IVF with no Traditional Chinese Medicine: Acupuncture
Active Comparator: IVF-Acupuncture
IVF with Traditional Chinese Medicine: Acupuncture
 Other: Traditional Chinese Medicine
Active arm will receive Acupuncture with their IVF cycle.
Other Name: Acupuncture

  Eligibility

Ages Eligible for Study:   21 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331395

Sponsors and Collaborators
Pacific Fertility Center
Investigators
Principal Investigator: Eldon Schriock, MD Pacific Fertility Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eldon Schriock, MD, Principal Investigator, Pacific Fertility Center
ClinicalTrials.gov Identifier: NCT01331395     History of Changes
Other Study ID Numbers: 2010.097-1 (Esch)
Study First Received: April 4, 2011
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pacific Fertility Center:
Infertility
IVF
Acupuncture

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013