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Endometrial Injury and IVF-ET Outcome

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
PIPELLE ENDOMETRIAL SAMPLING
Sponsored by
Bangalore Assisted Conception Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring invitro-fertilization ,embryo transfer,endometrial injury

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Bangalore Assisted Conception Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;

Secondary Outcome Measures

CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE

Full Information

First Posted
November 21, 2008
Last Updated
December 1, 2008
Sponsor
Bangalore Assisted Conception Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00796341
Brief Title
Endometrial Injury and IVF-ET Outcome
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 Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bangalore Assisted Conception Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
invitro-fertilization ,embryo transfer,endometrial injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
PIPELLE ENDOMETRIAL SAMPLING
Other Intervention Name(s)
Endometrial sampling
Intervention Description
Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.
Primary Outcome Measure Information:
Title
PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;
Time Frame
9 MONTHS
Secondary Outcome Measure Information:
Title
CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE
Time Frame
9 MONTHS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SACHIN A NARVEKAR, MD
Organizational Affiliation
Bangalore Assisted Conception Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangalore Assisted Conception Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560001
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
12798877
Citation
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. doi: 10.1016/s0015-0282(03)00345-5.
Results Reference
background
PubMed Identifier
34110001
Citation
Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
Results Reference
derived

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Endometrial Injury and IVF-ET Outcome

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