Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure

April 26, 2016 updated by: suzy abdelaziz Abdelhamid, Kasr El Aini Hospital

Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure.A Comparative Study

300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Group 1 consists of 100 patients will undergo endometrial scratch followed by controlled ovarian hyperstimulation Group 2 consists of 100 patients will undergo controlled ovarian hyperstimulation& assisted hatching Group 3 consists of 100 patients will undergo controlled ovarian hyperstimulation

Study Type

Interventional

Enrollment (Anticipated)

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

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • recurrent implantation failure
  • normal uterine cavity by transvaginal ultrasound

Exclusion Criteria:

  • endometrial polyp or fibroid distorting the endometrium
  • hydrosalpinx
  • preimplantation genetic diagnosis
  • severe male factor

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endometrial scratch group
endometrial scratch controlled ovarian hyperstimulation
Procedure: endometrial scratch
midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation
Other Names:
  • endometrial injury
Procedure: controlled ovarian hyperstimulation
using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol
Active Comparator: Assisted hatching group
assisted hatching controlled ovarian hyperstimulation
Procedure: controlled ovarian hyperstimulation
using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol
Procedure: assisted hatching
using Octax laser 20120644-laser 5452
Other Names:
  • laser hatching
Sham Comparator: ovarian stimulation only group
controlled ovarian hyperstimulation
Procedure: controlled ovarian hyperstimulation
using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients with positive pregnancy test
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: suzy abdelaziz, lecturer, kasrelaini hospital

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

May 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ivfobgyn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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