Endometrial Injury and IVF-ET Outcome

December 1, 2008 updated by: Bangalore Assisted Conception Centre

Does Endometrial Injury in the Non-Transfer Cycle Improve the IVF-ET Outcome in the Subsequent Cycle in Patients With Previous Failed IVF Cycles: A Randomized Control Trial

Implantation of the human embryo is the limiting factor in the success of invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in the subsequent cycle.We believe that the injury created causes release of substances which help in implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design and Subjects: This is a randomized control study designed to evaluate the effect of local injury to the endometrium in non-transfer cycle in patients with previous failed IVF.

Patients will be randomly allotted to control and intervention group The patients in the intervention group Pipelle endometrial sampling 7-10th day and 24-26th day in the cycle prior to IVF transfer cycle.

Outcome Measures: Clinical pregnancy rate,implantation rate and ongoing pregnancy rate.

SAMPLE SIZE: 100 PATIENTS (50 in each group).

Study Type

Interventional

Enrollment (Actual)

99

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

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560001
        • Bangalore Assisted Conception Centre

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 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Previous failed In-vitro fertilization embryo transfer cycle
  • Patients who are good responders and have good quality embryos in the previous attempts
  • Age of patients upto 37yrs

Exclusion Criteria:

  • Those detected to have endometrial tuberculosis in the past, including those treated with Antituberculosis treatment
  • Those with intramural fibroid distorting the endometrial cavity/sub-mucous myoma
  • Those with sonographically detected hydrosalpinx

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Procedure: PIPELLE ENDOMETRIAL SAMPLING
Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.
Other Names:
  • Endometrial sampling
No Intervention: 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;
Time Frame: 9 MONTHS
9 MONTHS

Secondary Outcome Measures

Outcome Measure
Time Frame
CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE
Time Frame: 9 MONTHS
9 MONTHS

Collaborators and Investigators

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

Sponsor

Bangalore Assisted Conception Centre

Investigators

  • Principal Investigator: SACHIN A NARVEKAR, MD, Bangalore Assisted Conception Centre

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

November 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimate)

November 24, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2008

Last Update Submitted That Met QC Criteria

December 1, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • endometrial injury study

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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