Fertility Disorders, Fertility Issues
Conditions
Keywords
infertility, insemination
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.
Interventions
PROCEDUREEndometrial Scratch
An endometrial biopsy pipelle will be used to create endometrial injury in the form of a scratch.
PROCEDURESham 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.
Sponsors
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are not made aware of which arm they are randomized to until after the cycle outcome has been determined.
Intervention model description
Participants are randomized to endometrial scratch or sham procedure (speculum insertion but no endometrial scratch)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed