Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT07212127
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
42 Years
Study:
NCT07212127
Study Brief:
Protocol Section:
NCT07212127