NCT04641598

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

August 31, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

November 18, 2020

Last Update Submit

August 2, 2021

Conditions

Fertility DisordersFertility Issues

Keywords

infertilityinsemination

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    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 Outcomes (2)

  • Time to conception

    To be assessed within 6 months of randomization.

  • Participants perceived acceptability

    The survey assessing this outcome is completed by the participant on the day of the study procedure.

Study Arms (2)

Endometrial scratch

EXPERIMENTAL

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 Suction will be applied and the pipelle will be completely withdrawn in a single pass.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

Sham procedure

SHAM COMPARATOR

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

Interventions

Endometrial ScratchPROCEDURE

An endometrial biopsy pipelle will be used to create endometrial injury in the form of a "scratch".

Also known as: Endometrial injury
Endometrial scratch
Sham procedurePROCEDURE

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.

Also known as: Sham
Sham procedure

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants are all undergoing intrauterine insemination and thus must have a uterus. This definition is based on anatomy rather than gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carilion Clinic Reproductive Medicine and Fertility

Roanoke, Virginia, 24016, United States

Location

Related Publications (1)

  • 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.

    PMID: 26538858BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Emily E Hoeker, MD

    Carilion Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not made aware of which arm they are randomized to until after the cycle outcome has been determined.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized to endometrial scratch or "sham" procedure (speculum insertion but no endometrial scratch)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physician

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 24, 2020

Study Start

August 31, 2018

Primary Completion

August 2, 2021

Study Completion

August 2, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)