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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04500522

Enrollment

150

Registered

2020-08-05

Start date

2020-09-01

Completion date

2021-09-15

Last updated

2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

Brief summary

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.

Detailed description

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.

Interventions

DRUGINH

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind randomized controlled trial

Intervention model description

double blind randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The difference in pain scores	10 minutes	Pain intensity will be assessed by visual analogue scale during the procedure. visual analogue scale ranging from 0 to 10

Secondary

Measure	Time frame	Description
Intensity of pain	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
Operative time	15 minutes	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026