ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 61 for:    "Genital Diseases, Female" | ( Map: India )

Endometrial Injury and IVF-ET Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00796341
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : December 2, 2008
Sponsor:
Information provided by:
Bangalore Assisted Conception Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Procedure: PIPELLE ENDOMETRIAL SAMPLING Not Applicable

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  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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 Name: Endometrial sampling

No Intervention: 2



Primary Outcome Measures :
  1. PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; [ Time Frame: 9 MONTHS ]

Secondary Outcome Measures :
  1. CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE [ Time Frame: 9 MONTHS ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: December 2, 2008
Last Verified: November 2008

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female