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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01331395 |
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Date of registration:
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04/04/2011 |
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Primary sponsor: |
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Public title:
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Effect of Traditional Chinese Medicine on In Vitro Fertilization (IVF) Success Rates
TCM-P002 |
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Scientific title:
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A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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276 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01331395 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Eldon Schriock, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pacific Fertility Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
42 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Primary Female Infertility
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Secondary Female Infertility
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Intervention(s)
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Other: Acupuncture
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Primary Outcome(s)
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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]
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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]
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Secondary Outcome(s)
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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]
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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]
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Secondary ID(s)
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2010.097-1 (Esch)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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