NCT02153814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

December 17, 2013

Last Update Submit

May 1, 2023

Conditions

Infertility

Keywords

InfertilityIn vitro fertilizationEndometrial injury

Outcome Measures

Primary Outcomes (1)

  • Live Birth Rate

    10 Months

Secondary Outcomes (5)

  • Pregnancy Rate

    2 months

  • Implantation Rate

    1 month

  • Spontaneous Abortion Rate

    4 months

  • 3-D Ultrasound Results - endometrial volume in mm^3

    1 month

  • Endometrial tissue gene expression levels (CT values)

    1 month

Study Arms (3)

Control

SHAM COMPARATOR

Will undergo sham procedure twice

Procedure: Sham procedure

One Endometrial Scratch Procedure

EXPERIMENTAL

Will undergo one sham procedure and one endometrial scratch procedure

Procedure: Endometrial Scratch

Two Endometrial Scratch Procedures

EXPERIMENTAL

Will undergo endometrial scratch procedure twice

Procedure: Endometrial Scratch

Interventions

Endometrial ScratchPROCEDURE

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.

Also known as: Endometrial biopsy, Endometrial injury, Endometrial pipelle
One Endometrial Scratch ProcedureTwo Endometrial Scratch Procedures
Sham procedurePROCEDURE

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

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medical Faculty Foundation, Division of Reproductive Endocrinology and Infertility

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Erica E Marsh, MD, MSCI

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Molly B Moravek, MD, MPH

    Northwestern University

    STUDY DIRECTOR

  • Randall Barnes, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

June 3, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2017

Study Completion

December 1, 2018

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations

US(1)