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Menstrual Phase Endometrial Scratch in IUI Cycles

Primary Purpose

Fertility Disorders, Fertility Issues

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endometrial Scratch
Sham procedure
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertility Disorders focused on measuring infertility, insemination

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Carilion Clinic Reproductive Medicine and Fertility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Endometrial scratch

Sham procedure

Arm Description

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 Suction will be applied and the pipelle will be completely withdrawn in a single pass.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.

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.

Outcomes

Primary Outcome Measures

Pregnancy rate
Obtaining a positive pregnancy test (urine or serum) at the conclusion of the treatment cycle in which the scratch was performed.

Secondary Outcome Measures

Time to conception
The amount of time between study randomization and positive pregnancy test.
Participants perceived acceptability
Participants rating of acceptability of the study procedure.

Full Information

First Posted
November 18, 2020
Last Updated
August 2, 2021
Sponsor
Carilion Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04641598
Brief Title
Menstrual Phase Endometrial Scratch in IUI Cycles
Official Title
The Effect of Menstrual Phase Endometrial Scratch on Intrauterine Insemination Cycle Outcomes and Participant Acceptability
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrollment is low and interim analysis demonstrated no difference in outcomes.
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
August 2, 2021 (Actual)
Study Completion Date
August 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Disorders, Fertility Issues
Keywords
infertility, insemination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to endometrial scratch or "sham" procedure (speculum insertion but no endometrial scratch)
Masking
Participant
Masking Description
Participants are not made aware of which arm they are randomized to until after the cycle outcome has been determined.
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endometrial scratch
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endometrial Scratch
Other Intervention Name(s)
Endometrial injury
Intervention Description
An endometrial biopsy pipelle will be used to create endometrial injury in the form of a "scratch".
Intervention Type
Procedure
Intervention Name(s)
Sham procedure
Other Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
Obtaining a positive pregnancy test (urine or serum) at the conclusion of the treatment cycle in which the scratch was performed.
Time Frame
Within one month from study randomization.
Secondary Outcome Measure Information:
Title
Time to conception
Description
The amount of time between study randomization and positive pregnancy test.
Time Frame
To be assessed within 6 months of randomization.
Title
Participants perceived acceptability
Description
Participants rating of acceptability of the study procedure.
Time Frame
The survey assessing this outcome is completed by the participant on the day of the study procedure.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants are all undergoing intrauterine insemination and thus must have a uterus. This definition is based on anatomy rather than gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily E Hoeker, MD
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Clinic Reproductive Medicine and Fertility
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not currently a plan to make IPD available to other researchers.
Citations:
PubMed Identifier
26538858
Citation
Wadhwa L, Pritam A, Gupta T, Gupta S, Arora S, Chandoke R. Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle. J Hum Reprod Sci. 2015 Jul-Sep;8(3):151-8. doi: 10.4103/0974-1208.165144.
Results Reference
background

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Menstrual Phase Endometrial Scratch in IUI Cycles

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