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NCT Number: NCT06637111

Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.

The study is conducted to assess whether ultrasound guidance can facilitate the access of the office hysteroscope into the uterine cavity of patients with previous failure of office hysteroscopy due to cervical stenosis.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo university, Cairo, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with history of failure of office hysteroscopy

Exclusion criteria

  • Pelvic inflammatory disease
  • Severe vaginal bleeding
  • Pregnancy
  • Allergy to lidocaine, prilocaine or diclofenac potassium

Treatment and study plan

Ultrasound guided office hysteroscopy group

Procedure

One hour before office hysteroscopy, 100 mg of diclofenac potassium will be administered per orem. The patients will be asked to drink about one liter of water and to avoid urination before the procedure Moreover, a few minutes prior to the office hysteroscopy, 3 ml of 5% lidocaine and prilocaine topical cream will be introduced into the endocervical canal.

All procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.

A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia.

Transabdominal ultrasound will be used to guide the access of the hysteroscope to the uterine cavity

Conventional office hysteroscopy group

Procedure

One hour before office hysteroscopy, 100 mg of diclofenac potassium will be administered per orem . The patients will be asked to drink about one liter of water and to avoid urination before the procedure Moreover, a few minutes prior to the office hysteroscopy, 3 ml of 5% lidocaine and prilocaine topical cream will be introduced into the endocervical canal.

All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.

A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia.

Primary outcomes

  1. Success of office hysteroscopy [ ability to gain access of the hysteroscope into uterine cavity]

    Time frame: Immediately after the procedure

    Percentage of successfully performed office hysteroscopy [ = number of successful office hysteroscopies /total number of office hysteroscopies]

Secondary outcomes

  1. Intensity of pain

    Time frame: Immediately after the procedure

    Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Usama M Fouda, Prof.

CONTACT

[email protected]

01095401375 ext. +2

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Bedaya Hospital

Registry information

Official study title

Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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