Electro-acupuncture and Assisted Reproductive Technology

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-03-31

Brief Summary

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One of the most widely used procedures in reproductive medicine technologies is In Vitro Fertilization (IVF). During the IVF procedure, there are sometimes unused embryos that are frozen to be used at later times. If these embryos are thawed and transferred back to the mother, proper development of the uterine lining plays an important role in outcome of pregnancy. Electro-acupuncture (EA), a technique where electrical current is applied to the needle to stimulate an acupoint, has been shown to increase uterine blood flow, increasing the likelihood of developing a more ideal endometrial lining. This randomized study aims to evaluate the impact of EA on endometrium undergoing medicated frozen embryo transfer cycle preparation. The treatment group will receive four acupuncture treatments during the medicated uterine preparation. Endometrial thickness will be compared to a group that does not receive acupuncture.

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Detailed Description

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All the subjects in the study will be randomized and their participation is completely voluntary. Patients recruited to join the study will not receive any monetary compensation for participation.

This research will include 100 female subjects, ages 21-45, undergoing medicated frozen embryo transfer (mFET). The subjects will be randomized into treatment and the non-treatment groups. The non-treatment group will undergo the medicated uterine preparation for FET according to the fertility clinic's protocol.

Subjects in the treatment group will receive four electro-acupuncture (EA) treatments in addition to the mFET protocol, starting after the 1st Ultrasound measurement which constitutes as a baseline, until the start of the progesterone administration. Endometrial thickness will be measured using ultrasound and estrogen (E2) levels will be measured by blood samples as a standard measure to assess the time of P4 (progesterone) supplementation. This step will be done by the participant's fertility clinic according to the clinic's protocol.

Acupuncture points of LI-4, LV-3, SP-6, Zi Gong, CV-3, CV-4, ST-36 will be needled. Electro-stimulation will be applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4 at low frequency. The needle retention with electro-stimulation will last for 25 minutes. After the 25 minutes, the needles and the electro-stimulation will be removed and the patients will be dismissed.

Ultrasound results measuring endometrium will be obtained from the subject's fertility clinic. US and bloodwork will be performed at baseline, and before the progesterone administration according to the fertility clinic. This US measurement and bloodwork results will be used for statistical analysis to compare endometrial lining of the two groups. The final discussion will be presented according to the findings.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electro-Acupuncture

Group will receive 4 acupuncture treatments over 14 days during hormone treatment

Group Type ACTIVE_COMPARATOR

Acupuncture, Electro-Acupuncture

Intervention Type PROCEDURE

Participants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment.

Control

Group will not receive acupuncture.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture, Electro-Acupuncture

Participants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing medicated frozen embryo transfer uterine preparation
* Ages between 21-45 years old
* Must be fluent in English
* Must be willing to receive four electro-acupuncture treatments
* Must be willing to provide access to medical records from the fertility clinic