Endometrial Injury and IVF-ET Outcome - Full Text View

Sponsored by:	Bangalore Assisted Conception Centre
Information provided by:	Bangalore Assisted Conception Centre
ClinicalTrials.gov Identifier:	NCT00796341

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

MedlinePlus related topics: Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment
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

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
1: Experimental	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.
2: No Intervention

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, KARNATAKA
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:

Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22.

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

Keywords provided by Bangalore Assisted Conception Centre:

invitro-fertilization ,embryo transfer,endometrial injury

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 15, 2009