Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility

April 10, 2015 updated by: Amr Abdulreheem, Ain Shams Maternity Hospital

Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility: A Randomized Control Trial

The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Proper history, examination and investigations are carried out to diagnose causes of infertility. Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. Controlled ovarian hyper stimulation-embryo transfer (COH-ET) using the standard long protocol of induction used in Ain Shams University Maternity Hospitals ART (assisted reproductive techniques) unit.

Biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.

Study Type

Interventional

Enrollment (Anticipated)

680

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 Contact

  • Name: Amr A. Abdulreheem, MBBCh
  • Phone Number: +201006774459
  • Email: amro984@gmail.com

Study Contact Backup

  • Name: Moustafa F Gomaa, PhD
  • Phone Number: 01226188993

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol.
  • No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
  • Patients with unexplained primary infertility.

Exclusion Criteria:

  • Patients undergoing IVF using other protocols of induction.
  • Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase.
  • Other causes of infertility rather than unexplained factor.
  • Unexplained poor responders during the pending ICSI cycle.
  • Patients with abnormal findings at hysteroscopy.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Undergoing Hysterosopy
This group will include 340 women with unexplained primary infertility undergoing their first trial of IVF/ICSI (intracytoplasmic sperm injection). This group will undergo hysteroscopy in the mid luteal phase of the proceeding cycle.
Procedure: Hysteroscopy

Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle.

All OH (office hysteroscopy) procedures will be performed with a vaginoscopic approach without utilizing a speculum and applying traction to the cervix with a tenaculum.

Antibiotic prophylaxis: None OH will be cancelled until after treatment of vaginal infection.

Other Names:
  • ROH: Routine Office Hysteroscopy
Device: Hysteroscope

The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 4-mm diameter diagnostic sheath with an atraumatic tip (Karl Storz Endoscopy).

Illumination: High intensity cold light source and fiberoptic cable Distention medium: solution of 0.9% normal saline with pressure at 100-120 mmHg
No Intervention: Group With No intervention
This group will include 340 women with unexplained primary infertility they will undergo their first trial of IVF/ICSI (intracytoplasmic sperm injection) without hysteroscopy in the mid Luteal phase of the proceeding cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Pregnancy
Time Frame: 2-6 weeks
Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks)
2-6 weeks

Collaborators and Investigators

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

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Study Director: Khaled H Swaydan, PhD, Ain Shams University (Obs&Gyn)
  • Study Chair: Ahmed K Mekled, PhD, Ain Shams University (Obs&Gyn)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 10, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASMH-RH1

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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