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Enrollment is low and interim analysis demonstrated no difference in outcomes.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 Suction will be applied and the pipelle will be completely withdrawn in a single pass.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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial Scratch | Procedure | An endometrial biopsy pipelle will be used to create endometrial injury in the form of a "scratch". |
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| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Participants are all undergoing intrauterine insemination and thus must have a uterus. This definition is based on anatomy rather than gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Emily E Hoeker, MD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic Reproductive Medicine and Fertility | Roanoke | Virginia | 24016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26538858 | Background | 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. |
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There is not currently a plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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Participants are randomized to endometrial scratch or "sham" procedure (speculum insertion but no endometrial scratch)
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Participants are not made aware of which arm they are randomized to until after the cycle outcome has been determined.
| Sham procedure | Procedure | 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. |
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| The survey assessing this outcome is completed by the participant on the day of the study procedure. |