Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles

September 19, 2014 updated by: mostafa fouad, Ain Shams Maternity Hospital
In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled study involving 300 patients with recurrent implantation failure

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams Maternity Hospital
        • Principal Investigator:
          • mostafa F gomaa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Invistigations
ICSI with long luteal phase protocol
Experimental: Hysteroscopy
hysteroscopy will be done prior to the ICSI cycle
Device: Hysteroscopy
hysteroscopy and endometrial injury prior to the IVF/ICSI cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• Clinical pregnancy rate.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
• Live Birth Rate
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
• Uterine anomalies detected by Hysteroscopy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: mostafa f gomaa, MD, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Routine Hysterscopy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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