Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies

Recruiting now · Not applicable

Conditions studied: Postmenopausal Women, Intrauterine Diseases, Endometrial Pathology, Postmenopausal Bleeding, Abnormal Uterine Bleeding (AUB)

In brief

The goal of this randomized controlled trial is to evaluate the effectiveness of different cervical preparation strategies before office hysteroscopy in postmenopausal women undergoing evaluation for intrauterine pathology. The main questions to answer are: Does cervical preparation improve the success rate of complete office hysteroscopy in postmenopausal women? Which cervical preparation strategy provides better patient tolerance, as assessed by pain intensity during the procedure? Researchers will compare four cervical preparation protocols (14-day vaginal estrogen, 7-day vaginal estrogen, oral misoprostol, and no cervical preparation) to determine their effects on procedural success, pain, procedure duration, and perioperative complications. Participants will be randomly assigned to one of the four cervical preparation protocols. They will undergo office hysteroscopy using a vaginoscopic ("no touch") approach without anesthesia. Then, they will have pain assessed using a visual analog scale (VAS) during the procedure. Finally, these informations will be collected: procedural success, procedure duration, bleeding, and perioperative complications.

Key facts

Study ID

NCT07697781

Run by

Faculty of Medicine of Tunis

People needed

120

Starts

2026-01-02

Expected to finish

2026-08-20

Last updated by the study team

2026-07-13

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with postmenopausal status.
• Scheduled for office hysteroscopy for the evaluation of suspected intrauterine pathology.
• Able to understand the study procedures and provide written informed consent.

You may not qualify if…

• Known or suspected hormone-dependent malignancy (e.g., breast or endometrial cancer).
• Active genital tract infection.
• Contraindication or known hypersensitivity to misoprostol or vaginal estrogen.
• Refusal to undergo office hysteroscopy without anesthesia.
• Active uterine bleeding preventing adequate hysteroscopic visualization on the day of the procedure.

Where it is running

• Maternity and neonatology center of Tunis — Tunis, Tunis Governorate, Tunisia (enrolling)

Full record on ClinicalTrials.gov

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