Menstrual Phase Endometrial Scratch in IUI Cycles

Carilion Clinic

Status: Terminated

Conditions: Fertility Disorders; Fertility Issues

Treatments: Procedure: Endometrial Scratch; Procedure: Sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04641598

IRB-20-1017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

Endometrial scratch

Experimental group

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.

Treatment:

Procedure: Endometrial Scratch

Sham procedure

Sham Comparator group

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.

Treatment:

Procedure: Sham procedure