Endometrial Injury and Implantation Rates Before First ICSI Cycle

January 31, 2024 updated by: Ahmed M Maged, MD, Cairo University

Does Local Endometrial Injury Improve Implantation Rates in Women Undergoing Their First ICSI Cycle.

Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure.

Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response).

Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is >=1 follicle >=18 mm. and >=3 follicles >=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos.

Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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, 12151
        • Kasr Alainy medical school

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

Description

Inclusion Criteria:

  1. subfertile women indicated for ICSI.
  2. normal uterine cavity demonstrated by transvaginal ultrasound and hystrogram.
  3. FSH<10mIU/mL on day 3 of her cycle.

Exclusion Criteria:

  1. presence of endometrial polyp or fibroid distorting the uterine cavity.
  2. hydrosalpinx.
  3. ICSI carried out for preimplantation genetic diagnosis.
  4. FSH>10mIU\mL.

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: endometrial scratch injury
endometrial scratch done before ICSI cycle
Procedure: Endometrial scratch injury
midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix
No Intervention: control
IcSI cycle without prior endometrial injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implantation rate
Time Frame: 14 days after embryo transfer
number of sacs identifiable through ultrasonography divided by the number of embryos transferred
14 days after embryo transfer
clinical pregnancy rate
Time Frame: 4 weeks after embryo transfer
the detection of fetal cardiac activity within a gestational sac on ultrasonography examination
4 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
multiple pregnancy rate
Time Frame: 4 weeks after embryo transfer
number of patients who had a multifetal pregnancy divided by the total number of clinical pregnancies
4 weeks after embryo transfer
abortion rate
Time Frame: 12 weeks of gestational age
number of patients who had a spontaneous abortion before 12 weeks of pregnancy divided by total number of clinical pregnancies
12 weeks of gestational age

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ahmed Maged, Kasr Alainy medical school

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 (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

January 17, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimated)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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