Transcutaneous Electrical Nerve Stimulation During Transvaginal Oocyte Retrieval
Condition: Transcutaneous Electric Nerve Stimulation; Oocyte Retrieval
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Transcutaneous electrical nerve stimulation; TENS machine with electrodes not emitting any impulses.
Intervention type(s): Device; Device
Intervention description(s): 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.; TENS machine with electrodes not emitting any impulses.
Other intervention name(s): Endomed 482
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oocyte Retrieval; Transcutaneous Electric Nerve Stimulation; Pain relief; Conscious sedation