Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures

NCT02611726 | Unknown Phase 3 DMC

• 1 other identifier: BnaiZionIVF
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertility; Pain

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Acupuncture treatment

ACTIVE COMPARATOR

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.

Other: Acupuncture

Control

NO INTERVENTION

Standard medical care during In-Vitro-Fertilization.

Interventions

Acupuncture OTHER

Acupuncture

Acupuncture treatment

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Any patient who under going an IVF treatment in the investigators' unit.

You may not qualify if:

• Patient who disagree to participate in the study,
• Patient who are undergoing ovulation induction or AID.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

MeSH Terms

Conditions

Infertility; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ilan Calderon, MD

  Deputy CEO, Bnai Zion Medical Center

  STUDY CHAIR

Central Study Contacts

Max Cohen, M.D

CONTACT

972506268302; medmax88@gmail.com

Elad Schiff, M.D

CONTACT

972506267243; elad.schiff@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 23, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: November 24, 2015

Record last verified: 2015-11