Menstrual Phase Endometrial Scratch in IUI Cycles

Carilion Clinic57 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fertility Disorders Fertility Issues

Interventions

Endometrial ScratchPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 37 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Carilion Clinic Reproductive Medicine and Fertility

Roanoke, Virginia, United States

Outcomes

Primary Outcomes

Pregnancy rate

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 Outcomes

Time to conception

The amount of time between study randomization and positive pregnancy test.

Time frame: To be assessed within 6 months of randomization.

Participants perceived acceptability

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.

Data from ClinicalTrials.gov

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