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Endometrial Injury and in Vitro Fertilization Outcomes

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ClinicalTrials.gov Identifier: NCT02153814
Recruitment Status : Unknown
Verified February 2016 by Erica Marsh, Northwestern University.
Recruitment status was:  Recruiting
First Posted : June 3, 2014
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Erica Marsh, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Endometrial Scratch Procedure: Sham procedure Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study on the Effect of Endometrial Injury in Patients Undergoing in Vitro Fertilization (IVF)
Study Start Date : August 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Sham Comparator: Control
Will undergo sham procedure twice
Procedure: Sham procedure
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

Experimental: One Endometrial Scratch Procedure
Will undergo one sham procedure and one endometrial scratch procedure
Procedure: Endometrial Scratch
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.
Other Names:
  • Endometrial biopsy
  • Endometrial injury
  • Endometrial pipelle

Experimental: Two Endometrial Scratch Procedures
Will undergo endometrial scratch procedure twice
Procedure: Endometrial Scratch
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.
Other Names:
  • Endometrial biopsy
  • Endometrial injury
  • Endometrial pipelle




Primary Outcome Measures :
  1. Live Birth Rate [ Time Frame: 10 Months ]

Secondary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 2 months ]
  2. Implantation Rate [ Time Frame: 1 month ]
  3. Spontaneous Abortion Rate [ Time Frame: 4 months ]
  4. 3-D Ultrasound Results - endometrial volume in mm^3 [ Time Frame: 1 month ]
  5. Endometrial tissue gene expression levels (CT values) [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153814


Locations
United States, Illinois
Northwestern Medical Faculty Foundation, Division of Reproductive Endocrinology and Infertility Recruiting
Chicago, Illinois, United States, 60611
Contact: Gricelda Mendoza    312-472-0286    gricelda.mendoza1@northwestern.edu   
Principal Investigator: Erica E Marsh, MD, MSCI         
Sub-Investigator: Molly B Moravek, MD, MPH         
Principal Investigator: Randall Barnes, MD         
Sponsors and Collaborators
Northwestern University
Northwestern Memorial Hospital
Investigators
Principal Investigator: Erica E Marsh, MD, MSCI Northwestern University
Study Director: Molly B Moravek, MD, MPH Northwestern University
Principal Investigator: Randall Barnes, MD Northwestern University

Responsible Party: Erica Marsh, Assistant Professor, Division of Reproductive Endocrinology and Infertility, Northwestern University
ClinicalTrials.gov Identifier: NCT02153814     History of Changes
Other Study ID Numbers: NW-STU00075489
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Erica Marsh, Northwestern University:
Infertility
In vitro fertilization
Endometrial injury

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female