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

NCT01331395 | Terminated

• 1 other identifier: 2010.097-1 (Esch)
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Primary Female Infertility; Secondary Female Infertility

Keywords

Infertility; IVF; Acupuncture

Outcome Measures

Primary Outcomes (2)

• 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

  Average of 1 year

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

  Overall to be collected at interim analysis of 138 subjects and at study completion of 276 patients

Secondary Outcomes (2)

• 1. The proportion of subjects who undergo an embryo transfer which results in implantation as evidenced by USS at 7 weeks.

  Average of 4 months

• 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).

  Average of two months

Study Arms (2)

IVF-No Acupuncture

NO INTERVENTION

IVF with no Traditional Chinese Medicine: Acupuncture

IVF-Acupuncture

ACTIVE COMPARATOR

IVF with Traditional Chinese Medicine: Acupuncture

Other: Traditional Chinese Medicine

Interventions

Traditional Chinese Medicine OTHER

Active arm will receive Acupuncture with their IVF cycle.

Also known as: Acupuncture

IVF-Acupuncture

Eligibility Criteria

• Age: 21 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacific Fertility Center: lead

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Interventions

Medicine, Chinese Traditional; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Eldon Schriock, MD

  Pacific Fertility Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 8, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 29, 2015

Record last verified: 2015-10