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

Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Diagnostic Office Hysteroscopy: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02823119

Enrollment

100

Registered

2016-07-06

Start date

2016-08-31

Completion date

2017-06-30

Last updated

2016-07-06

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

Conditions

Pain

Keywords

Mini-hysteroscopy, Office hysteroscopy, Pain

Brief summary

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

Detailed 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.

Interventions

DEVICEMini-hysteroscopy

Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm. All of the procedures will be diagnostic.

DEVICEConventional Office Hysteroscopy

. Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm. All of the procedures will be diagnostic.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Nulliparous patients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Intensity of pain	up to 30 minutes	Intensity of pain assessed by the Visual Analog Scale (VAS)

Secondary

Measure	Time frame
Duration of procedure	intraoperative

Countries

Egypt

Contacts

Primary ContactUsama M Fouda, M.D, PhD

umfrfouda@yahoo.com

Outcome results

None listed

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