Infertility Clinical Trial
— AcupunctIVFOfficial title:
Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing In Vitro Fertilization (IVF)
Verified date | September 2020 |
Source | Texas Tech University Health Sciences Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Experimental Approach: (1) Participants: Women (ages 21 to 42) who seek IVF treatment at the Center for Fertility & Reproductive Surgery will be eligible for the study. Seventy women will be recruited and randomly assigned to either the intervention (acupuncture plus standard care) or the comparison (standard care alone) group. (2) Intervention: Participants in the intervention group will receive 3 acupuncture sessions during the project with the first treatment between day 6-8 of the stimulated IVF cycle, second on the day of embryo transfer and the third one day post transfer. Participants in the comparison group will receive no intervention but will receive standard care. (3) Measures: The primary outcome measures include prostacyclin and thromboxane vasoactive biomarkers. Secondary outcome measures include perceived stress levels. (4) Procedure: Upon IRB approval, an informed consent will be provided to all participants. Pre- and post- acupuncture urinary metabolites of prostacyclin and thromboxane will be assessed. A standardized Perceived Stress Scale will be administered before and after each acupuncture session for the study group, and before and after a 30-40-minute waiting period for the control group.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 42 Years |
Eligibility |
Inclusion Criteria: - Women between ages 21-42 years seeking IVF. - Willing to undergo acupuncture - No contraindications to needle insertion. Exclusion Criteria: - Women currently using alternative therapies such as acupressure, herbal supplements and meditation techniques. - Women with generalized psoriasis, neuropathy or coagulopathies posing increased risk due to needle insertion. - Women with previous experience with acupuncture. ***Please note that we are unable to give a discount on IVF cost for participating in the study.*** |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech Health Science Center | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center |
United States,
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* Note: There are 62 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine prostacyclin before and after acupuncture | Measurement of the vasoactive molecule prostacyclin (pg/mg creatinine) in women undergoing IVF therapy. | Within 8-week course of IVF treatment | |
Primary | Urine thromboxane before and after acupuncture | Measurement of the vasoactive molecule thromboxane (pg/mg creatinine) in women undergoing IVF therapy. | Within 8-week course of IVF treatment |
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