About this trial
Office hysteroscopy is a cornerstone in the diagnostic evaluation of infertile women, enabling direct visualization of the uterine cavity for identifying intrauterine pathology. The vaginoscopic ("no-touch") approach, which eliminates the use of a speculum and tenaculum, is increasingly adopted due to improved tolerability, higher success rates, and reduced pain compared to conventional methods.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
o Women aged 18-40 years.
Diagnosis of primary infertility (failure to conceive after ≥12 months of unprotected intercourse).
Indication for diagnostic office hysteroscopy.
Regular menstrual cycles.
Disqualifiers
o Secondary infertility.
Known pelvic infection, cervicitis, or vaginitis.
Use of analgesics within 8 hours prior to procedure.
Cervical stenosis, prior failed hysteroscopy, or known uterine anomaly.
Trial design
Parallel
Treatments tested in this trial
verbal analgesia
BehavioralProviders will deliver a standardized verbal analgesia script in a calm, slow-paced, supportive tone, synchronized to procedural steps: * Scope introduction (introitus → external os): "You may feel light pressure as the camera enters-keep a slow, steady breath; you are doing well." * Cervical passage (internal os): "A brief pinch or cramp may happen now; it will pass quickly-breathe in slowly, and out." * Uterine entry and distension: "A feeling of fullness is expected; stay with your breath-it eases in moments." * Cavity inspection: "You may notice short waves of cramp; they are normal and brief-you're managing this well." * Withdrawal: "We are nearly finished-slow exhale as we come out. That's it, you did great." Providers will undergo training to ensure fidelity. All participants will receive ibuprofen 600 mg orally one hour before hysteroscopy as standard analgesia.
standard care
BehavioralProviders will use neutral, procedural statements without supportive phrasing, e.g., "Starting the camera now," "Passing the cervix," "Entering the uterus," "Inspecting the cavity," "Withdrawing the camera.". All participants will receive ibuprofen 600 mg orally one hour before hysteroscopy as standard analgesia.
Treatment groups
Trial outcomes
Primary outcomes
pain during OH
It will be measured by 0-10 numerical rating scale where 0 indicates no pain and 10 worst pain imaginable
Secondary outcomes
Patient satisfaction
Patient satisfaction on a 0-10 NRS (0 = no satisfaction, 10 = maximum satisfaction).
Sponsors and contacts
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Cairo University
Lead sponsor
Aljazeera Hospital
Collaborator