Menstrual Phase Endometrial Scratch in IUI Cycles

August 2, 2021 updated by: Emily Evans-Hoeker, Carilion Clinic

The Effect of Menstrual Phase Endometrial Scratch on Intrauterine Insemination Cycle Outcomes and Participant Acceptability

Patients undergoing treatment with intrauterine insemination (IUI) will be randomized to receive an endometrial scratch or sham procedure during the menstrual phase of the treatment cycle.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Infertility is a common issue faced by many couples throughout the United States. There are multiple fertility treatment options, including in vitro fertilization (IVF) and intrauterine insemination (IUI). Additionally, methods such as endometrial scratch (a modified endometrial biopsy) have been postulated to increase success rate. This prospective, randomized control trial will assess whether performing an endometrial scratch improves cycle outcomes and decreases time to pregnancy following IUI. Each patient will be randomly assigned to receive either an endometrial scratch or undergo a "sham" procedure (speculum insertion but no scratch) during the menstrual phase of the IUI cycle.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic Reproductive Medicine and Fertility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patients undergoing intrauterine insemination procedures between the ages of 18 and 37 who have undergone a complete fertility work up (tubal, uterine, hormonal and sperm assessments) and do not have a current tubal or uterine factor infertility or severe male factor (expected to have < 10 million total motile sperm on IUI sample) unless using donor sperm.

Exclusion Criteria:

  • age < 18 or > 37, expectation (prior to randomization) of < 10 million total motile sperm on IUI sample, tubal factor, uterine factor, incomplete fertility work up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Endometrial scratch
A speculum will be inserted into the vagina and the cervix cleansed with betadine (or alternative if allergy). The cervix will be grasped with a single tooth tenaculum and an endometrial biopsy pipelle inserted into the uterine cavity to the depth of the uterine fundus. Suction will be applied and the pipelle will be completely withdrawn in a single pass. All instruments will be removed from the vagina after hemostasis is ensured.
Procedure: Endometrial Scratch
An endometrial biopsy pipelle will be used to create endometrial injury in the form of a "scratch".
Other Names:
  • Endometrial injury
SHAM_COMPARATOR: Sham procedure
A speculum will be inserted into the vagina and the cervix cleansed with betadine (or alternative if allergy). The motions of grasping the cervix with a single tooth tenaculum and inserting the biopsy pipelle will be simulated, but not actually performed. All instruments will then be removed from the vagina.
Procedure: Sham procedure
Motions of performing an endometrial scratch will be performed including speculum placement and cervix cleansing, however, placement of the tenaculum and the endometrial scratch will not be performed.
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: Within one month from study randomization.
Obtaining a positive pregnancy test (urine or serum) at the conclusion of the treatment cycle in which the scratch was performed.
Within one month from study randomization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to conception
Time Frame: To be assessed within 6 months of randomization.
The amount of time between study randomization and positive pregnancy test.
To be assessed within 6 months of randomization.
Participants perceived acceptability
Time Frame: The survey assessing this outcome is completed by the participant on the day of the study procedure.
Participants rating of acceptability of the study procedure.
The survey assessing this outcome is completed by the participant on the day of the study procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Investigators

  • Principal Investigator: Emily E Hoeker, MD, Carilion Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2018

Primary Completion (ACTUAL)

August 2, 2021

Study Completion (ACTUAL)

August 2, 2021

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (ACTUAL)

November 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20-1017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not currently a plan to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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