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

Not Applicable

Terminated

• Conditions: Primary Female Infertility; Secondary Female Infertility
• Interventions: Other: Traditional Chinese Medicine

• Registration Number: NCT01331395
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-08
• Study Start: 2011-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVF-Acupuncture	Traditional Chinese Medicine	IVF with Traditional Chinese Medicine: Acupuncture

Primary Outcome Measures

Name	Time	Method
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
The proportion of subjects who receive an embryo transfer which results in a live birth.	Average of 1 year	Embryo transfer resulting in Live Birth up to 40 weeks gestation

Secondary Outcome Measures

Name	Time	Method
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	Repeat measures at Screening, Treatment Month and at Embryo Transfer
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	At 7 week ultrasound