Physical Endometrial Manipulation and Its Effect on ICSI

August 28, 2021 updated by: Mahmoud Alalfy, Aljazeera Hospital

Physical Endometrial Manipulation and Its Effect on Success Rate in Patients With Previous ICSI Failure

Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate

Study Type

Interventional

Enrollment (Actual)

640

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
      • Giza, Egypt
        • Algazeerah

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Infertile female age 20-35 years
  • Previous Failed one ICSI trial
  • normal basal hormonal profile [FSH, LH] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity
  • patent tubes
  • normal Husband semen analysis

Exclusion Criteria:

  • Ovarian factor of infertility
  • Tubal factor of infertility
  • Endometrial factor of infertility
  • Male factor of infertility

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: manipulation of endometrium
The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching
Device: Hydrotubation
Other Names:
  • Sonohysterography
  • Endometrial scratching
Placebo Comparator: no manipulation to endometrium in ICSI
This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group
Device: Hydrotubation
Other Names:
  • Sonohysterography
  • Endometrial scratching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants who achieved clinical pregnancy
Time Frame: 6 weeks after embryo transfer
Describes how many participant will continue pregnancy after positive pregnancy test
6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants who achieved ongoing pregnancy and live birth
Time Frame: 9 months after embryo transfer
Describes who many participant will continue pregnancy till he had birth and a live birth
9 months after embryo transfer

Collaborators and Investigators

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

Sponsor

Aljazeera Hospital

Investigators

  • Study Chair: Mahmoud Alalfy, master, Algazeerah hospital -Location (Giza -Egypt )

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 (Actual)

January 3, 2017

Primary Completion (Actual)

December 25, 2017

Study Completion (Actual)

December 28, 2017

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 28, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Algazeerah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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