search
Back to results

Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hysteroscopy
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring hysteroscopy - recurrent implantation failure

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient's age ranged from 20-40 years.
  2. Normal appearance of the uterine cavity on hysterosalpingography.
  3. Patients prepared for IVF/ICSI cycle.

Exclusion Criteria:

  1. Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases).
  2. Patients with uterine cavity pathology previously known to the examiner.
  3. Patients with previous uterine surgery such as myomectomy.
  4. Patients with abnormal HSG.

Sites / Locations

  • Ain Shams Maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine Invistigations

Hysteroscopy

Arm Description

ICSI with long luteal phase protocol

hysteroscopy will be done prior to the ICSI cycle

Outcomes

Primary Outcome Measures

• Clinical pregnancy rate.

Secondary Outcome Measures

• Live Birth Rate

Full Information

First Posted
April 24, 2014
Last Updated
September 19, 2014
Sponsor
Ain Shams Maternity Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02245750
Brief Title
Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.
Detailed Description
A randomized controlled study involving 300 patients with recurrent implantation failure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
hysteroscopy - recurrent implantation failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine Invistigations
Arm Type
No Intervention
Arm Description
ICSI with long luteal phase protocol
Arm Title
Hysteroscopy
Arm Type
Experimental
Arm Description
hysteroscopy will be done prior to the ICSI cycle
Intervention Type
Device
Intervention Name(s)
Hysteroscopy
Intervention Description
hysteroscopy and endometrial injury prior to the IVF/ICSI cycle
Primary Outcome Measure Information:
Title
• Clinical pregnancy rate.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
• Live Birth Rate
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
• Uterine anomalies detected by Hysteroscopy
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient's age ranged from 20-40 years. Normal appearance of the uterine cavity on hysterosalpingography. Patients prepared for IVF/ICSI cycle. Exclusion Criteria: Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases). Patients with uterine cavity pathology previously known to the examiner. Patients with previous uterine surgery such as myomectomy. Patients with abnormal HSG.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Mohammed, MbbcH
Phone
00201110362860
Email
ahmadmarzok85@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa f gomaa, MD
Phone
01226188993
Email
mostafafouadg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mostafa f gomaa, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Maternity hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mostafa F gomaa, MD

12. IPD Sharing Statement

Learn more about this trial

Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles

We'll reach out to this number within 24 hrs