Clinical trial NCT02153814: Endometrial Injury and in Vitro Fertilization Outcomes
Official title: Pilot Study on the Effect of Endometrial Injury in Patients Undergoing in Vitro Fertilization (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility
In vitro fertilization
Endometrial injury
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern Memorial Hospital
First posted: 2014-06-03
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women undergoing IVF at the Northwestern Medical Faculty Foundation, Division of Reproductive Endocrinology and Infertility
* Age at time of egg retrieval 18-40 years, inclusive. Age at time of embryo transfer 18-45 years, inclusive.
* All subjects must have given signed, informed consent prior to registration in study

Exclusion Criteria:

* Patients with any current uterine pathology known to affect implantation, such as large hydrosalpinx, Asherman's syndrome, fibroids or polyps
* Patients with active cervical or pelvic infection
* Pregnant women
* Patients with a serious bleeding diathesis (e.g. hemophilia)

Primary outcomes:
measure: Live Birth Rate
timeFrame: 10 Months
Secondary outcomes:
measure: Pregnancy Rate
timeFrame: 2 months
measure: Implantation Rate
timeFrame: 1 month
measure: Spontaneous Abortion Rate
timeFrame: 4 months
measure: 3-D Ultrasound Results - endometrial volume in mm^3
timeFrame: 1 month
measure: Endometrial tissue gene expression levels (CT values)
timeFrame: 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation, Division of Reproductive Endocrinology and Infertility
state: Illinois
Study officials:
affiliation: Northwestern University
name: Erica E Marsh, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Molly B Moravek, MD, MPH
role: STUDY_DIRECTOR
affiliation: Northwestern University
name: Randall Barnes, MD
role: PRINCIPAL_INVESTIGATOR
References: