Endometrial Injury and IVF-ET Outcome

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796341
• Other study ID #: endometrial injury study
• Status: Completed
• Phase: N/A
• First received: November 21, 2008
• Last updated: December 1, 2008
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: November 2008
• Source: Bangalore Assisted Conception Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• PIPELLE 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.

Locations

Country	Name	City	State
India	Bangalore Assisted Conception Centre	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Bangalore Assisted Conception Centre

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRIMARY OUTCOME MEASURE:IMPLANTATION RATE;		9 MONTHS
Secondary	CLINICAL PREGNANCY RATE,ONGOING PREGNANCY RATE		9 MONTHS