Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures
NCT ID: NCT02611726
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2015-12-31
2017-05-31
Brief Summary
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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.
Detailed Description
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After IVF stimulation protocol the patients in the acupuncture group will have three acupuncture treatments: The first will take place right after oocytes retrieval and the second treatment will be right before embryo transfer, and lastly 20-30 minutes after embryo transfer. Patients in the control group will receive standard care only. Patients in both groups will fill out questionnaires regarding expectations from complementary medicine (likert scale no expectation--high expectation), anxiety level (Visual Analogue Scale= VAS) before the procedures, as well as pain assessment (VAS) before and after the IVF procedures. In addition, a general satisfaction questionnaire from the overall care at the IVF unit will be completed at the last visit (likert scale very unsatisfied--highly satisfied). Finally, the physicians will report procedure ease or complexity on a likert scale (very easy-very difficult).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Acupuncture treatment
Individualized acupuncture needle insertion according to traditional Chinese and Japanese medicine on top of standard medical care during In-Vitro-Fertilization. Acupuncture needles will be inserted to body surface points following traditional diagnosis (anamnesis, tongue, pulse and abdomen inspection) according to practitioner discretion.
Acupuncture
Acupuncture
Control
Standard medical care during In-Vitro-Fertilization.
No interventions assigned to this group
Interventions
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Acupuncture
Acupuncture
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient who are undergoing ovulation induction or AID.
20 Years
44 Years
FEMALE
Yes
Sponsors
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Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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Max.Cohen
M.D
Principal Investigators
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Ilan Calderon, MD
Role: STUDY_CHAIR
Deputy CEO, Bnai Zion Medical Center
Central Contacts
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Other Identifiers
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BnaiZionIVF
Identifier Type: -
Identifier Source: org_study_id