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CompletedNCT00796341Updated Dec 2, 2008

Endometrial Injury and IVF-ET Outcome

An interventional study of PIPELLE ENDOMETRIAL SAMPLING in Infertility, sponsored by Bangalore Assisted Conception Centre. Completed at 1 site in India. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2008-12-02.

Sponsored by Bangalore Assisted Conception Centre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years to 37 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Infertility

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Keywords

  • invitro-fertilization ,embryo transfer,endometrial injury
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 99 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

This is the only study on the registry with Bangalore Assisted Conception Centre as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Experimental
    1

    Procedure: PIPELLE ENDOMETRIAL SAMPLING

  • No intervention
    2

Interventions

  • ProcedurePIPELLE 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.

    Also known as: Endometrial sampling

06

What researchers measure

Primary outcomes

  1. PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;

    Time frame: 9 MONTHS

Secondary outcomes

  1. CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE

    Time frame: 9 MONTHS

07

Study locations

1 site
  • Bangalore Assisted Conception Centre
    Bangalore, Karnataka 560001, India
08

References and documents

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. doi: 10.1016/s0015-0282(03)00345-5. PubMed 12798877 ↗
  • 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. PubMed 34110001 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00796341
Lead sponsor
Bangalore Assisted Conception Centre
First posted
Nov 24, 2008
Start date
Nov 2007
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Dec 2, 2008

Study contacts

SACHIN A NARVEKAR, MD
principal investigator · Bangalore Assisted Conception Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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