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NCT Number: NCT00796341

Endometrial Injury and IVF-ET Outcome

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bangalore Assisted Conception Centre

Bangalore, Karnataka, 560001, India

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PIPELLE ENDOMETRIAL SAMPLING

Procedure

Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.

Other names: Endometrial sampling

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

Sponsors and collaborators

Lead sponsor

Bangalore Assisted Conception Centre

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 24, 2008
Registry last updated
Dec 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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