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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01331395
Recruitment Status : Terminated (Enrollment rate slower than anticipated.)
First Posted : April 8, 2011
Last Update Posted : October 29, 2015
Information provided by (Responsible Party):
Pacific Fertility Center

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Female Infertility Secondary Female Infertility Other: Traditional Chinese Medicine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The proportion of subjects who receive an embryo transfer which results in a live birth. [ Time Frame: Average of 1 year ]
    Embryo transfer resulting in Live Birth up to 40 weeks gestation

  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    At 7 week ultrasound

  2. 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 ]
    Repeat measures at Screening, Treatment Month and at Embryo Transfer

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01331395

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

Additional Information:
Responsible Party: Pacific Fertility Center Identifier: NCT01331395     History of Changes
Other Study ID Numbers: 2010.097-1 (Esch)
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015

Keywords provided by Pacific Fertility Center:

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