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Completed

NCT Number: NCT04500522

Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

To compare the effectiveness of vaginal isonicotinic acid hydrazide with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aswan University Hospital

Aswān, 81528, Egypt

About this study

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

Exclusion criteria

  • women with suspected pregnancy
  • heavy vaginal bleeding
  • recent pelvic infection
  • those known to have hypersensitivity or contraindication to isonicotinic acid hydrazide
  • those who received analgesics prior to office heavy vaginal bleeding
  • recent pelvic infection
  • a concomitant neurologic disease that could affect the correct evaluation of pain

Treatment and study plan

INH

Drug

3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.

Other names: isonicotinic acid hydrazide

Placebo

Drug

3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Primary outcomes

  1. The difference in pain scores

    Time frame: 10 minutes

    Pain intensity will be assessed by visual analogue scale during the procedure. visual analogue scale ranging from 0 to 10

Secondary outcomes

  1. Intensity of pain

    Time frame: 30 minutes after the procedure

    Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10

  2. Operative time

    Time frame: 15 minutes

    From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2020
Registry last updated
Sep 29, 2021

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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