Menstrual Phase Endometrial Scratch in IUI Cycles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2021-08-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fertility Disorders Fertility Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized to endometrial scratch or "sham" procedure (speculum insertion but no endometrial scratch)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants are not made aware of which arm they are randomized to until after the cycle outcome has been determined.

Study Groups

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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.

Group Type EXPERIMENTAL

Endometrial Scratch

Intervention Type PROCEDURE

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

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.

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type 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.

Interventions

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Endometrial Scratch

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

Intervention Type PROCEDURE

Sham 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.

Intervention Type PROCEDURE

Other Intervention Names

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Endometrial injury Sham

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes