Pain Clinical Trial
Official title:
Effectiveness of Acupuncture Added to Standard Care Vs Standard Care Alone During In-Vitro-Fertilization: A Randomized Controlled Trial
Rationale for conducting the experiment: Israel performed IVF treatments since 1980.
Although ART (Advanced Reproductive Treatments) have evolved over the years implantation and
pregnancy rates have not met the expectations yet. Success rates of fertility treatments are
about 15-18% (clinical pregnancy rates =CPR). As a result additional methods (clinical,
technological and complimentary) have been tried to improve the CPR.
In some reviews the effects of acupuncture practice during fertility treatments showed
certain benefits, including pain relief and relaxation. Unfortunately those trials were not
randomized and lacked methodological rigor.
The aim of this study is to evaluate the effect of acupuncture on pain, anxiety, and CPR of
women undergoing IVF as compared to standard care alone.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | May 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Any patient who under going an IVF treatment in the investigators' unit. Exclusion Criteria: - Patient who disagree to participate in the study, - Patient who are undergoing ovulation induction or AID. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bnai Zion Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety before In-Vitro-Fertilization pickup assessed using Visual Analogue Scales (no anxiety 0-10 worst anxiety). | Anxiety will be reported by patients on Visual Analogue Scales (VAS). Mean change in anxiety level will be compared between groups. | Before and after acupuncture treatments prior to IVF 15 minutes before pickup and 15 minutes after pickup. | No |
Primary | Pain level during In-Vitro-Fertilization pickup assessed using Visual Analogue Scale (no pain 0-10 worst pain) | Pain will be reported by patients on Visual Analogue Scales (VAS). Mean pain level will be compared between groups. | Pain during pickup will be assessed 15 minutes after pickup. | No |
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