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The effect of endometrial local injury in increasing pregnancy rate

Phase 3
Conditions
Infertility.
Female infertility
Registration Number
IRCT201302091141N13
Lead Sponsor
Royan Institute
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.<br /> 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 (at least =1 cycles have failed). <br /> Patients will be randomly allotted to control and intervention group. The patients in the intervention group Pipelle endometrial sampling 19-21th day (biopsy in luteal) in the cycle prior to IVF transfer cycle.<br /> Outcome Measures: Clinical pregnancy rate, implantation rate and ongoing pregnancy rate.<br />

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
220
Inclusion Criteria

Inclusion Criteria: Previous failed In-vitro fertilization embryo transfer cycle (at least =1 cycles have failed); Patients who are good responders and have good quality embryos in the previous attempts; Age of patients up to 40 years.

Exclusion Criteria

Those with intramural fibroid distorting the endometrial cavity/sub-mucous myoma; Those with sonographically detected hydrosalpinx; age over than 40 years old; poor responders to ovarian stimulation.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical pregnancy. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: Ultrasound visualization of a gestational sac.
Secondary Outcome Measures
NameTimeMethod
Biochemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: BhCG test.;Implantation. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: Number of sacs by Sonography.;Endometrial thickness. Timepoint: Third day. Method of measurement: Sonography.;Early abortion. Timepoint: Week 12. Method of measurement: Sonography.;Late abortion. Timepoint: Week 20. Method of measurement: Sonography.
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