NCT02245750

Brief Summary

In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

April 24, 2014

Last Update Submit

September 19, 2014

Conditions

Infertility

Keywords

hysteroscopy - recurrent implantation failure

Outcome Measures

Primary Outcomes (1)

  • • Clinical pregnancy rate.

    6 months

Secondary Outcomes (1)

  • • Live Birth Rate

    6 months

Other Outcomes (1)

  • • Uterine anomalies detected by Hysteroscopy

    6 months

Study Arms (2)

Routine Invistigations

NO INTERVENTION

ICSI with long luteal phase protocol

Hysteroscopy

EXPERIMENTAL

hysteroscopy will be done prior to the ICSI cycle

Device: Hysteroscopy

Interventions

HysteroscopyDEVICE

hysteroscopy and endometrial injury prior to the IVF/ICSI cycle

Hysteroscopy

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • mostafa f gomaa, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Mohammed, MbbcH

CONTACT

00201110362860ahmadmarzok85@gmail.com

mostafa f gomaa, MD

CONTACT

01226188993mostafafouadg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Value of Routine Hysteroscopy prior to IVF/ICSI Cycles: A Randomized Control Trial

Study Record Dates

First Submitted

April 24, 2014

First Posted

September 22, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations

EG(1)