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

NCT ID: NCT01331395

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

IVF-No Acupuncture

IVF with no Traditional Chinese Medicine: Acupuncture

Group Type: NO_INTERVENTION

No interventions assigned to this group

IVF-Acupuncture

IVF with Traditional Chinese Medicine: Acupuncture

Group Type: ACTIVE_COMPARATOR

Traditional Chinese Medicine

Intervention Type: OTHER

Active arm will receive Acupuncture with their IVF cycle.

Interventions

Traditional Chinese Medicine

Active arm will receive Acupuncture with their IVF cycle.

Intervention Type: OTHER

Other Intervention Names

Acupuncture

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pacific Fertility Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eldon Schriock, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Fertility Center

Related Links

http://www.pacificfertilitycenter.com/

Related Info

Other Identifiers

2010.097-1 (Esch)

Identifier Type: -

Identifier Source: org_study_id