NCT00796341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
Last Updated

December 2, 2008

Status Verified

November 1, 2008

Enrollment Period

10 months

First QC Date

November 21, 2008

Last Update Submit

December 1, 2008

Conditions

Keywords

invitro-fertilization ,embryo transfer,endometrial injury

Outcome Measures

Primary Outcomes (1)

  • PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;

    9 MONTHS

Secondary Outcomes (1)

  • CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE

    9 MONTHS

Study Arms (2)

1

EXPERIMENTAL
Procedure: PIPELLE ENDOMETRIAL SAMPLING

2

NO INTERVENTION

Interventions

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
1

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangalore Assisted Conception Centre

Bangalore, Karnataka, 560001, India

Location

Related Publications (2)

  • 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.

    PMID: 12798877BACKGROUND
  • 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.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • SACHIN A NARVEKAR, MD

    Bangalore Assisted Conception Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 2, 2008

Record last verified: 2008-11

Locations