Transcutaneous Electrical Nerve Stimulation During Transvaginal Oocyte Retrieval

February 26, 2019 updated by: The University of Hong Kong

Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Relief During Transvaginal Oocyte Retrieval Using Conscious Sedation

This randomized double-blinded control trial aims to compare the pain levels experienced by the women using the standard conscious sedation and those who had transcutaneous electrical nerve stimulation (TENS) in addition to conscious sedation. The hypothesis is that there will be less pain in women with both conscious sedation and TENS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women who are indicated to undergo IVF in our center will be assessed for eligibility for the study. Written consent will be obtained from those who agreed to join the study.

Eligible women recruited will be randomized according to a computer-generated randomization list prepared by a designated research staff into one of the two groups on the day of oocyte retrieval

  1. Patient with both conscious sedation and active TENS
  2. Patient with conscious sedation and placebo TENS

Blinding Both the women and the physician performing the procedure will be blinded from the group allocation.

Checking of effectiveness of blinding will be done by asking the patient and the physician after the procedure as to which group they think the women is in.

The procedure Women will receive ovarian stimulation according to the departmental Standard Operating Procedures. Ovarian stimulation will be monitored by ultrasound. Human chorionic gonadotrophin or an agonist (decapeptyl) will be given when the dominant follicle is at least 18mm and there are three more follicles of at least 16mm. Oocyte retrieval will then be arranged 36 hours later.

Prior to oocyte retrieval, two sets of self-adhesive electrodes will be placed on the women back on each side of the spine at T10 to S4 level. Instructions on how to titrate the TENS amplitude to the desired level that gives a strong non-painful electrical paraesthesia will be given to the women by the research nurse who is unaware of the group allocation. TENS therapy will start 5 minutes before the procedure and stop 5 minutes after the removal of oocyte aspiration needle. The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses s-. The women in the treatment group will be given a TENS machine with electrodes emitting impulses while those in the placebo group will be given a TENS machine with electrodes that is not emitting any impulses.

The woman lies on the operative bed in a lithotomy position. 25mg Pethidine and 5mg Diazepam will be given intravenously. The blood pressure and pulse of the woman are checked after the drug administration and the oxygen saturation is monitored continuously throughout the procedure. 10ml 1% lignocaine is injected to the paracervical region by the operating surgeon with a 21-gauge needle after cleansing the vagina and cervix with chlorhexidine. Under transvaginal ultrasound guidance, a 16-gauge ovum aspiration needle is introduced. Aspiration of follicles is performed with a suction pressure of 100 mmHg.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Department of Obstetrics and Gynaecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who undergo transvaginal oocyte retrieval

Exclusion Criteria:

  • There is only one ovary
  • Oocyte retrieval performed on one ovary only
  • There are less than three follicles >=16mm in diameter
  • Allergic to pethidine or midazolam
  • Previous experience with TENS
  • Skin damage or allergy at site of TENS pads application
  • History of pacemaker insertion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group
Transcutaneous electrical nerve stimulation machine, start 5 minutes before start of oocyte retrieval and stop 5 minutes after removal of oocyte retrieval needle
Device: Transcutaneous electrical nerve stimulation
The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses.
Other Names:
  • Endomed 482
Sham Comparator: Placebo group
TENS machine with electrodes not emitting any impulses, start 5 minutes before start of oocyte retrieval and stop 5 minutes after removal of oocyte retrieval needle
Device: TENS machine with electrodes not emitting any impulses.
TENS machine with electrodes not emitting any impulses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: 1 day on the day of the retrieval procedure
The women will be asked to rate the pain according to a 100mm linear visual analogue scale. The visual analogue scale range from 0 to 100, 0 indicating no pain and 100 indicating maximum pain. A small value in the visual analogue scale indicates lower pain levels, therefore better. It is a single level indicated by the patients.
1 day on the day of the retrieval procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 1 day on the day of the retrieval procedure
Side effects experienced by the women
1 day on the day of the retrieval procedure
Women satisfaction
Time Frame: 1 day on the day of the retrieval procedure
Patient's satisfaction towards pain relief will be assessed before discharge. They will be rated as 5, 'excellent'; 4, 'satisfactory'; 3, 'fair'; 2,'not very satisfactory' and 1, 'totally unsatisfactory.
1 day on the day of the retrieval procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Ernest HY Ng, MD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2018

Primary Completion (Actual)

October 15, 2018

Study Completion (Actual)

October 15, 2018

Study Registration Dates

First Submitted

February 25, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TENS TUGOR ver 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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