Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures

Bnai Zion Medical Center

Status and phase: Unknown; Phase 3

Conditions: Infertility; Pain

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02611726

BnaiZionIVF

Details and patient eligibility

About

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.

Full description

Women planned for IVF at the investigators' institution will be offered to participate in this trial. Following consent, women will be randomized to acupuncture in addition to standard care OR standard care only according to the working days of the acupuncture practitioner (working alternately three days a week).

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).

Enrollment: 400 estimated patients

Sex: Female

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Acupuncture treatment

Active Comparator group

Description:

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.

Treatment:

Other: Acupuncture

Control

No Intervention group

Description:

Standard medical care during In-Vitro-Fertilization.