Endometrial Injury and IVF-ET Outcome

This study has been completed.
Sponsor:
Information provided by:
Bangalore Assisted Conception Centre
ClinicalTrials.gov Identifier:
NCT00796341
First received: November 21, 2008
Last updated: December 1, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention
Infertility
Procedure: PIPELLE ENDOMETRIAL SAMPLING

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bangalore Assisted Conception Centre:

Primary Outcome Measures:
  • PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; [ Time Frame: 9 MONTHS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE [ Time Frame: 9 MONTHS ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Endometrial sampling
No Intervention: 2

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).

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796341

Locations
India
Bangalore Assisted Conception Centre
Bangalore, Karnataka, India, 560001
Sponsors and Collaborators
Bangalore Assisted Conception Centre
Investigators
Principal Investigator: SACHIN A NARVEKAR, MD Bangalore Assisted Conception Centre
  More Information

Publications:
Responsible Party: Dr Kamini A Rao, Bangalore Assisted Conception Centre
ClinicalTrials.gov Identifier: NCT00796341     History of Changes
Other Study ID Numbers: endometrial injury study
Study First Received: November 21, 2008
Last Updated: December 1, 2008
Health Authority: India: Institutional Review Board

Keywords provided by Bangalore Assisted Conception Centre:
invitro-fertilization ,embryo transfer,endometrial injury

Additional relevant MeSH terms:
Infertility
Wounds and Injuries
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014