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

Primary Purpose

Primary Female Infertility, Secondary Female Infertility

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Traditional Chinese Medicine
Sponsored by
Pacific Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Female Infertility focused on measuring Infertility, IVF, Acupuncture

Eligibility Criteria

21 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    IVF-No Acupuncture

    IVF-Acupuncture

    Arm Description

    IVF with no Traditional Chinese Medicine: Acupuncture

    IVF with Traditional Chinese Medicine: Acupuncture

    Outcomes

    Primary Outcome Measures

    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
    The proportion of subjects in the active treatment group experiencing no SAE's attributable to ACU.

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    April 4, 2011
    Last Updated
    October 27, 2015
    Sponsor
    Pacific Fertility Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01331395
    Brief Title
    Effect of Traditional Chinese Medicine on In Vitro Fertilization (IVF) Success Rates
    Acronym
    TCM-P002
    Official Title
    A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    Enrollment rate slower than anticipated.
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pacific Fertility Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Female Infertility, Secondary Female Infertility
    Keywords
    Infertility, IVF, Acupuncture

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IVF-No Acupuncture
    Arm Type
    No Intervention
    Arm Description
    IVF with no Traditional Chinese Medicine: Acupuncture
    Arm Title
    IVF-Acupuncture
    Arm Type
    Active Comparator
    Arm Description
    IVF with Traditional Chinese Medicine: Acupuncture
    Intervention Type
    Other
    Intervention Name(s)
    Traditional Chinese Medicine
    Other Intervention Name(s)
    Acupuncture
    Intervention Description
    Active arm will receive Acupuncture with their IVF cycle.
    Primary Outcome Measure Information:
    Title
    The proportion of subjects who receive an embryo transfer which results in a live birth.
    Description
    Embryo transfer resulting in Live Birth up to 40 weeks gestation
    Time Frame
    Average of 1 year
    Title
    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 Measure Information:
    Title
    1. The proportion of subjects who undergo an embryo transfer which results in implantation as evidenced by USS at 7 weeks.
    Description
    At 7 week ultrasound
    Time Frame
    Average of 4 months
    Title
    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).
    Description
    Repeat measures at Screening, Treatment Month and at Embryo Transfer
    Time Frame
    Average of two months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject is able to understand and provide consent Subject is female, 21-42 years of age at time of screening and has at least one l ovary Subject BMI is > 18 and < 32 Subject is experiencing primary or secondary infertility Subject may receive sperm from donated source Subject's partner has sperm in the ejaculate Subject's serum basal FSH is < 11 IU/L Subject's serum basal estradiol level is between 20-80 pg/mL Subject's TSH level is < 3.0 mv/mL Subject's prolactin level is < 24 ng/mL Subject will agree to limit caffeine intake to one cup (76.5 mL/day) by the time of randomization 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 Subject agrees not to participate in any other research opportunities for the duration of the study Exclusion Criteria: Subject is pursuing sex selection Subject is undergoing treatment with an egg donor Subject experienced more than 2 previous failed cycles Subject is undergoing a heparin or lovenox-based protocol Subject is currently taking herbal therapy (1 week wash-out) Subject is currently taking co-interventions of moxibustion and cupping Subject is exhibiting uterine anomalies (i.e.,bicornuate, unicornuate uterus,) Subject is diagnosed with severe endometriosis defined as endometriomas > 4cm Subject is currently receiving acupuncture therapy (Subject must agree to a 30 day washout period prior to randomization) Subject has history of recurrent spontaneous abortions defined as > 3 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eldon Schriock, MD
    Organizational Affiliation
    Pacific Fertility Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.pacificfertilitycenter.com/
    Description
    Related Info

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