Status:
NOT_YET_RECRUITING
Analgesic Effect of TENS-WAA Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery
Lead Sponsor:
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Conditions:
Oocyte Retrieval for IVF
Pain
Eligibility:
FEMALE
21-42 years
Phase:
NA
Brief Summary
This study is a single-centre randomised controlled trial. It aimed to evaluate the efficacy and safety of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory(TENS-WAA)...
Eligibility Criteria
Inclusion
- Females aged between 21 and 42 years.
- Patients diagnosed with infertility requiring oocyte retrieval for in vitro fertilisation-embryo transfer.
- Body Mass Index (BMI) 18.5 ≤ BMI ≤ 29.9 kg/m².
- Regular menstrual cycles with ultrasound monitoring demonstrating dominant follicle development and ovulation during the natural cycle; good ovarian reserve: follicle-stimulating hormone (FSH) \< 10 IU/L, antral follicle count (AFC) \> 6, anti-Müllerian hormone (AMH) \> 1.5 ng/ml.
- Undergoing ovarian stimulation therapy using follicle-stimulating hormone (FSH) or gonadotropin protocols.
- Electing tramadol hydrochloride injection for analgesia during oocyte retrieval.
- Voluntary participation with signed written informed consent.
Exclusion
- History of other chronic pain conditions, or prolonged use of opioid medications, history of anaesthetic drug addiction, or chronic alcohol abuse.
- Severe pelvic adhesions.
- Presence of pacemakers or other implanted medical electronic devices.
- Concurrent use of high-frequency surgical equipment, artificial heart-lung machines, medical shortwave therapy, or microwave therapy devices.
- Presence of scarring or skin lesions at electrode application sites.
- Severe anxiety, depression, or other psychiatric conditions impairing accurate description of sensations, or any other disorders potentially affecting pain perception.
- Conditions contraindicating or affecting oocyte retrieval, such as coagulation disorders, acute pelvic inflammation, vaginitis, trichomoniasis, endometriomas, ovarian cysts.
- Individuals with laparoscopically and/or ultrasonographically confirmed endometriosis.
- Patients with ovarian hyporesponsiveness following conventional ovarian stimulation medication.
Key Trial Info
Start Date :
November 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07212127
Start Date
November 8 2025
End Date
December 31 2026
Last Update
October 8 2025
Active Locations (1)
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1
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China, 200433