Menstrual Phase Endometrial Scratch in IUI Cycles

Not Applicable

Terminated

• Conditions: Fertility Disorders; Fertility Issues
• Interventions: Procedure: Sham procedure; Procedure: Endometrial Scratch

• Registration Number: NCT04641598
• Lead Sponsor: Carilion Clinic

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.

Study Timeline

• Study Start: 2018-08-31
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-24
• Status Verified: 2021-08
• Primary Completion: 2021-08-02
• Study Completion: 2021-08-02
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham procedure	Sham procedure	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.
Endometrial scratch	Endometrial Scratch	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.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	Within one month from study randomization.	Obtaining a positive pregnancy test (urine or serum) at the conclusion of the treatment cycle in which the scratch was performed.

Secondary Outcome Measures

Name	Time	Method
Time to conception	To be assessed within 6 months of randomization.	The amount of time between study randomization and positive pregnancy test.
Participants perceived acceptability	The survey assessing this outcome is completed by the participant on the day of the study procedure.	Participants rating of acceptability of the study procedure.

Trial Locations

Locations (1)

Carilion Clinic Reproductive Medicine and Fertility; 🇺🇸 Roanoke, Virginia, United States