Endometrial Injury and IVF-ET Outcome

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: PIPELLE ENDOMETRIAL SAMPLING

• Registration Number: NCT00796341
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-11
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Last Update Submitted: 2008-12-01
• Last Update Posted: 2008-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PIPELLE ENDOMETRIAL SAMPLING	-

Primary Outcome Measures

Name	Time	Method
PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;	9 MONTHS

Secondary Outcome Measures

Name	Time	Method
CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE	9 MONTHS

Trial Locations

Locations (1)

Bangalore Assisted Conception Centre; 🇮🇳 Bangalore, Karnataka, India