Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Office Hysteroscopy

Cairo University (CU)

Status and phase: Unknown; Phase 2

Conditions: Pain

Treatments: Device: Conventional Office Hysteroscopy; Device: Mini-hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02823119

Hysteroscope size & pain

Details and patient eligibility

About

The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

Full description

The results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. Several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nulliparous patients

Exclusion criteria

• Parous patients, menopausal status, cervical pathology, and previous cervical surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Mini-hysteroscopy

Experimental group

Description:

A rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm.

Treatment:

Device: Mini-hysteroscopy

Conventional Office Hysteroscopy

Active Comparator group

Description:

A rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm

Treatment:

Device: Conventional Office Hysteroscopy