Effect of Acupuncture on Vascular Biomarkers and Psychological Well-Being of Women Undergoing IVF

NCT ID: NCT02591186

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2020-09-01

Brief Summary

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.

Detailed Description

Hypothesis and Specific Aims

The purpose of this pilot study is to determine if acupuncture affects the vasoactive molecules (prostacyclin and thromboxane) in women undergoing IVF therapy. The investigators' overall hypotheses for this area of study, to be addressed with future research, are: (1) acupuncture augments IVF success by enhancing the perfusion of pelvic organs including the ovaries and the uterus, and (2) acupuncture reduces the levels of stress and optimizes mind-body interaction in individuals undergoing IVF.

Specific Aims:

1. To measure urine prostacyclin and thromboxane, before and after acupuncture, and

2. to assess the impacts of acupuncture on the psychological well-being of women undergoing IVF treatment.

SIGNIFICANCE OF THE STUDY Results from this study will shed light on the mechanism by which acupuncture improves IVF outcomes. This may lead to other treatment strategies to improve success. Likewise, an established mechanism by which acupuncture improves IVF may lead to greater acceptance of this non-conventional treatment modality by the general population.

Research Design and Methods

This is a prospective, randomized, controlled study. Participants will be women in the Principal Investigator's practice seeking IVF. Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group. Each group will have 3 study visits.

Rationale for the Control Group:

A sham control group is not used because systematic review suggested that sham acupuncture controls may unnecessarily complicate the RCT evidence base given the nature of objective outcomes in IVF study (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3124624/).

Power analysis

With 35 patients allocated to each group, assuming the Student's T-test will be used to determine the differences between two independent samples, effect sizes d>0.6 will be found statistically significant with alpha .05 and power .80. In practical terms, since the PSS validation samples showed a mean about 13.5 with variance=6.2, only averaged differences greater than 1.5 raw score points in PSS will be found statistically significant.

The investigators plan to seek extramural funding in the future. The investigators will use the data obtained from this pilot study to perform power analysis and to calculate the number of participants needed in future proposals.

Conditions

Infertility

Study Design

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

Study Groups

Acupuncture arm

Participants receiving acupuncture during IVF process

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Participants will receive 3 acupuncture sessions during IVF process

Control

Control arm not receiving acupuncture during IVF process

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

Participants will receive 3 acupuncture sessions during IVF process

Intervention Type: PROCEDURE

Eligibility Criteria

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.***

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

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer L Phy, DO

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

Locations

Texas Tech Health Science Center

Lubbock, Texas, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

L15-117

Identifier Type: -

Identifier Source: org_study_id