Endometrial Injury and in Vitro Fertilization Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Women's Studies, Infertility |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | December 2018 |
Pilot Study on the Effect of Endometrial Injury in Patients Undergoing in Vitro Fertilization (IVF)
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.
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.
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.
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.
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)
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Erica E Marsh, MD, MSCI
Phone: 312-472-0286
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