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

A Randomized, Controlled Clinical Trial of the Effect of Traditional Chinese Medicine on IVF Success Rates

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

Study Overview

• Status: Terminated
• Conditions: Primary Female Infertility; Secondary Female Infertility
• Intervention / Treatment: Other: Traditional Chinese Medicine

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Repeat measures at Screening, Treatment Month and at Embryo Transfer	Average of two months

Collaborators and Investigators

• Sponsor: Pacific Fertility Center
• Investigators: Principal Investigator: Eldon Schriock, MD, Pacific Fertility Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 6, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: IVF; Infertility; Acupuncture
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 2010.097-1 (Esch)