Endometrial Injury and in Vitro Fertilization Outcomes
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Infertility affects 1 in 7 couples worldwide. The most successful treatment is in vitro
      fertilization (IVF), a procedure where a woman's eggs are collected and fertilized with sperm
      to make embryos, which are then placed in the woman's uterus using a small catheter, a
      procedure called "embryo transfer." Unfortunately, pregnancy rates from IVF are less than
      50%. Recently, several studies have shown dramatically improved pregnancy rates by grazing
      the innermost lining of the uterus (the endometrium) with a small flexible catheter weeks
      prior to embryo transfer. These studies were all performed outside the United States (U.S.)
      in women with multiple failed IVF attempts and did not investigate the mechanisms by which
      endometrial injury works. This study will be the first to evaluate the effect of endometrial
      injury on IVF success in all women undergoing IVF, including first IVF cycles, frozen embryo
      transfers, and donor eggs.
    

Detailed description: 
      Nationally, the percentage of in vitro fertilization (IVF) cycles resulting in pregnancy is
      still less than 50%, even in optimal patients. While failed implantation may be due to embryo
      factors, in recent years much attention has been given to the role of endometrial receptivity
      at the time of embryo transfer. There is abundant evidence in the literature showing that, in
      women with repeated implantation failures despite having high quality embryos, endometrial
      injury performed either in the follicular phase of the IVF cycle or late in the cycle
      preceding the treatment cycle increases IVF success rates, often more than doubling the
      pregnancy rate.

      The mechanism of improved pregnancy rates after endometrial injury is currently unknown.
      There is a paucity of studies in the current literature linking the biochemical and genetic
      changes induced by endometrial injury to pregnancy rates in patients undergoing IVF, as well
      as studies examining the effect of endometrial injury on ultrasound findings previously shown
      to predict IVF success, such as endometrial thickness, pattern, and volume, or markers of
      endometrial vascularity.

      Additionally, no studies have been published examining whether or not IVF success rates can
      be improved in all-comers (not just women with repeated failures or abnormal appearing
      endometrium on ultrasound) by performing endometrial injury and there are currently no
      studies published on this topic with U.S. women in the study population. The proposed study
      would be the first to examine the effect of endometrial injury in U.S. women undergoing
      infertility treatment with IVF, regardless of prior treatment history, including women
      undergoing donor oocyte IVF cycles or frozen embryo transfer. It would also be the first to
      evaluate the biochemical changes induced by endometrial injury in the context of cycle
      outcome and live birth rate and to examine the effect on ultrasound parameters.
    

Intervention name(s): Endometrial Scratch; Sham procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): After cleansing the cervix with Betadine, the procedure will be performed using a 3mm endometrial sampling curette, with three passes made of the endometrium along the length of the fundus. Patients will be given the option to take ibuprofen 600mg one hour prior to the scheduled procedure. The first endometrial scratch procedure or sham procedure will be performed up to two weeks prior to expected menses, and the second endometrial scratch or sham procedure will be performed cycle day 5-11 of the stimulation cycle.; For the sham procedure, after cleansing the cervix with betadine, the endometrial sampling curette will be placed 2-3cm into the cervix without entering the uterine cavity
Other intervention name(s): Endometrial biopsy; Endometrial injury; Endometrial pipelle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Infertility; In vitro fertilization; Endometrial injury