Comparing Two Types of Endometrial Activation Prior to Embryo Transfer
Condition: Infertility; Endometrial Disorder
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To determine if two types of endometrial activation (Pipelle curette or Shepard catheter)
      prior to embryo transfer result in similar live birth rates. Also to determine if patients
      experience similar pain from both types of endometrial activation.
    

Detailed description: 
      Assisted reproductive technologies (ART), including in vitro fertilization (IVF), are methods
      used to treat infertility, which affects approximately 10% reproductive aged women.
      Physicians at the Women's Institute perform over 300 embryo transfer procedures every year.
      Despite advances and improvements in ART over the past three decades, clinical pregnancy rate
      and live birth rate remain 30-40% and 20-30%. Implantation is essential for successful ART
      and IVF procedures, and many interventions have been studied to possibly improve implantation
      rates and thus pregnancy and live birth rates.

      Endometrial activation is one such intervention, sometimes referred to as endometrial
      "activation" or "scratch," and it is defined as "intentional endometrial injury, such as
      endometrial biopsy or curettage, in women undergoing ART".

      A previous study found that implantation rates, clinical pregnancy rates, and live birth
      rates were more than twofold higher in women who underwent endometrial biopsy in the cycle
      before subsequent IVF treatment. Another study which examines endometrial activation prior to
      IVF similarly has concluded that endometrial activation prior to the embryo transfer cycle
      significantly improves clinical pregnancy rates and live birth rates in women undergoing ART.
      Although the type of endometrial procedure is not specified, the timing activation was found
      be most effective when performed in the cycle prior to the embryo transfer.

      The mechanism of increase endometrial receptivity is still unknown; however three proposed
      hypothesis exist. The first hypothesis proposes that local activation of the endometrium
      induces endometrial decidualization which increases the probability of embryo implantation.
      The second hypothesis is that endometrial healing following endometrial activation increases
      secreted cytokines, interleukins, growth factors, macrophages, and dendritic cells which are
      beneficial to embryo implantation. The final hypothesis suggests that endometrial maturation
      is abnormally advanced during ovarian stimulation, so endometrial activation may lead to
      better synchronicity between the endometrium and the embryo..

      Endometrial activation has been found to have clear benefit in pregnancy and live birth rates
      in a previous study, however no uniform technique has been determined. The objective of this
      study is to compare two types of endometrial disruption - a vigorous endometrial biopsy with
      a Pipelle curette and a four quadrant endometrial "scratch" using a Shepard insemination
      catheter - to determine if the live birth rates are equivalent for the two methods. The
      investigators also will compare pain with the two types of endometrial activation. By
      comparing two distinct types of endometrial activation, the goal is to determine which method
      is both effective and tolerable to patients.

      The Shepherd catheter is a 1.8 mm malleable insemination catheter that can be curved to
      traverse the cervix. It is also used by some physicians in the Women's Institute to perform
      saline infusion sonography. When the catheter is inserted under ultrasound guidance, it is
      often placed in the subendometrial tissue, and causes deflection and disruption of the
      endometrium but is tolerated well. The Pipelle is a 3.1 mm semi-rigid catheter with an
      internal stylet plunger. A biopsy is performed by placing the catheter into the uterus,
      withdrawing the stylet to create suction, and aspirating endometrial tissue into the
      catheter.

      A study done by Leclair et al. found that the mean pain that women had when the Pipelle was
      used for an endometrial biopsy was 6.2±2.4 on a visual analog scale from 1-10 (5). Pain with
      the Shepard catheter has not been studied when it is used for endometrial biopsy.
    

Intervention name(s): Endometrial scratch with Pipelle curette; Endometrial scratch with Shepard catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.; For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
Other intervention name(s): Endometrial activation, endometrial injury; Endometrial activation, endometrial injury
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel treatment arms for two types of endometrial scratch
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometrial scratch