Endometrial Assessment of Women With Uterine Infection

September 23, 2023 updated by: Aljazeera Hospital

Endometrial Assessment Women With Infertility Who Will do IUI and ICSI

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Implantation is the main rate limiting step in IVF outcome. Implantation is described at the cellular and the molecular levels by adhesion or fixation of a good quality embryo to receptive endometrium within a critical period of time, which is called the window of implantation

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Algazeerah and Kasralainy hospital
        • Contact:
        • Contact:
          • Ahmed Elgazzar, M.D
          • Phone Number: +201014005959
        • Principal Investigator:
          • Mahmoud Alalfy, master

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

Yes

Description

Inclusion Criteria:

  • Women with infertility age from 20-40 years

Exclusion Criteria:

  • Any 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hysteroscopic evaluation
Hysteroscopic evaluation Active group : infection Manipulation of endometrium with saline
Procedure: manipulation of endometrium
Manipulation of endometrium with saline
Other Names:
  • Saline infusion
Other: control group
Hysteroscopic evaluation Control group : No infection
Procedure: manipulation of endometrium
Manipulation of endometrium with saline
Other Names:
  • Saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of women who will get pregnant after IUI
Time Frame: within 4 weeks
How many women will get pregnant after IUI
within 4 weeks

Collaborators and Investigators

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

Sponsor

Aljazeera Hospital

Investigators

  • Principal Investigator: Mahmoud Alalfy, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre 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)

February 2, 2019

Primary Completion (Estimated)

May 3, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uterine infection

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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