Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis

NCT03457350 | Completed DMC

• 1 other identifier: hysteroscopy versus probing
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to estimate if performing a small caliber office hysteroscopic cervical negotiation would succeed to bypass tight markedly stenotic cervix in comparison to blind cervical probing done under general anesthesia. Moreover, the investigators test the impact of drawing a detailed diagram after this procedure on the success of ET in participants with failed mock or actual trials of embryo transfer (ET).

Conditions

Hysteroscopy

Keywords

hysteroscopy; cervical stenosis; probing

Outcome Measures

Primary Outcomes (1)

• How many cases of access to the endometrial cavity

  overcoming cervical stenosis

  20 minutes

Secondary Outcomes (1)

• complication rate

  20 minutes

Study Arms (2)

office hysteroscopy

EXPERIMENTAL

Office hysteroscopy 30 degrees 2.6 mm telescope with an outer sheath of 3.2 mm (Storz Co., Tutlingen, Germany). Hysteroscopy is performed as usual by proper examination of the vagina and the ectocervix for any abnormality followed by introduction of the hysteroscope into the cervical canal. At this step, the hysteroscopist waits for a while until the distending fluid forms a micro-cavity. At this point, the telescope is advanced with necessary rotatory movements of the 30 degrees telescope guided by the vision of the dark spot which is the internal os. If it is reached, again waiting for some time to allow fluid distension of the internal os area.

Procedure: cervical negotiation

blind cervical probing

EXPERIMENTAL

Cervical probing is started with a 2 mm probe after grasping the cervix with a multi-tooth tenaculum put anteriorly or posteriorly according to prior transabdominal or transvaginal sonographic examination of the cervical canal. If the probe succeedes to bypass the internal os, a higher caliber probe is used. Thereafter, a uterine sound (4mm = 1.33 Fr) is introduced into the endometrial cavity. Lastly, gentle cervical dilatation up to Hegar's 8 is performed as usual with classic leaving each dilator for 30 seconds inside the internal os. If probes couldn't bypass the internal os, the procedure is considered failed. If the probe enters a cavity other than endometrial cavity, a false passage is considered.

Procedure: cervical negotiation

Interventions

cervical negotiation PROCEDURE

trial to bypass severe cervical stenosis

blind cervical probing; office hysteroscopy

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliprous women.
• Failed cervical sounding on vaginal examination in the office.

You may not qualify if:

• Previous operation on the cervix.
• Use of any medication to prime the cervix (primary).
• Multiparity: weather delivered vaginally or by cesarean sectrion

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

Location

Study Officials

• Atef Darwish

  Woman's |Health University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr Atef Darwish MD PhD

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 7, 2018
• Study Start: January 1, 2012
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)