Menstrual Phase Endometrial Scratch in IUI Cycles

Study Overview
=================
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.

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

Conditions
-----------------
Fertility Disorders, Fertility Issues

Intervention / Treatment
-----------------
* Procedure: Endometrial Scratch
* Procedure: Sham procedure


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized to endometrial scratch or sham procedure (speculum insertion but no endometrial scratch)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial scratch<br>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<br>* An endometrial biopsy pipelle will be used to create endometrial injury in the form of a scratch.<br>* Other names: Endometrial injury;|
| Sham Comparator: Sham procedure<br>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<br>* 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.<br>* Other names: Sham;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to conception | The amount of time between study randomization and positive pregnancy test. | To be assessed within 6 months of randomization. | 
| Participants perceived acceptability | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, insemination