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

Pacific Fertility Center

Status

Terminated

Conditions

Primary Female Infertility

Secondary Female Infertility

Treatments

Other: Traditional Chinese Medicine

Study type

Interventional

Funder types

Other

Identifiers

NCT01331395

2010.097-1 (Esch)

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

Female

Ages

21 to 42 years old

Volunteers

Accepts Healthy Volunteers

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.