Local Endometrial Injury in Fresh Embryo Transfer Cycles

Summary

The application of in-vitro fertilization (IVF) has provided remarkable opportunities for infertile couple to conceive in the last four decades. Historically IVF was performed for patients with bilateral tubal obstruction, but its use is presently widespread. Although the efficacy of assisted reproductive technology continues to improve, endometrial implantation remains the limiting step towards a successful pregnancy. Reduced endometrial receptivity and embryonic defects are the probable primary causes of implantation failure during IVF(1). Patients with repeated implantation failure despite transferring good-quality embryos continue to be a major dilemma for clinicians and are a topic of great research interest. Barash et al. unintentionally discovered and initially reported that an endometrial biopsy prior to IVF in women who have had one or more implantation failures was associated with an increased clinical pregnancy (66.7% vs 30.3%, p\<0.01) and live birth rates 48.9% vs 22.5%, p=0.02) compared to a control group(2). The mechanism by which a local endometrial injury (LEI) may increase the pregnancy rate is still not fully clear. Possible etiologies include its role in promoting a beneficial local inflammatory response, inducing endometrial decidualization, or improving endometrial maturation synchrony (3-6).

Following Barash et al's publication, several randomized controlled studies confirmed their findings (7-11). However, there has been extensive heterogeneity among studies, including the number of biopsies, how the biopsy is performed and the selected patient population. On the other hand all the studies have in common that the endometrial biopsy was performed prior to the start of the IVF cycle.

The optimal timing of an endometrial biopsy with respect to an IVF cycle is unknown. There is reason to suspect that an endometrial biopsy during the follicular phase of an IVF stimulation cycle may improve pregnancy outcomes, although this has not been directly examined. We therefore propose a randomized controlled study to evaluate the impact of an endometrial biopsy on the implantation and pregnancy rate in both the luteal phase prior to the IVF cycle as well as the follicular phase of the concurrent IVF cycles.

Conditions

• Infertility

Interventions

PROCEDURE

Endometrial Biopsy

The Local Endometrial Injury will be performed using the standard technique using a Pipelle sampling catheter in the outpatient department. After a speculum examination is performed and the cervix is well visualized, the Pipelle will be inserted gently through the cervical canal into the uterine cavity and advanced slowly until resistance is noted. At this point the internal piston is withdrawn to create negative suction and the Pipelle is gently maneuvered up and down alongside the uterine cavity wall. The Pipelle catheter is then withdrawn gently and any obtained specimen (uterine lining) will be sent for histopathological examination.

Sponsors & Collaborators

• McGill University

  lead OTHER

Principal Investigators

• Dan Nayot, BSc; MSc; MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Togas Tulandi, MD, MHCM · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Hananel Holzer, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

36 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• Canada

Study Locations