Menstrual Phase Endometrial Scratch in IUI Cycles

Fertility Disorders Clinical Trial

Official title:

The Effect of Menstrual Phase Endometrial Scratch on Intrauterine Insemination Cycle Outcomes and Participant Acceptability

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04641598
• Other study ID #: IRB-20-1017
• Status: Terminated
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: August 2, 2021

Study information

• Verified date: August 2021
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: August 2, 2021
• Est. primary completion date: August 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fertility Disorders
• Fertility Issues
• Infertility

Intervention

Procedure:
• Endometrial Scratch
An endometrial biopsy pipelle will be used to create endometrial injury in the form of a "scratch".
• 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.

Locations

Country	Name	City	State
United States	Carilion Clinic Reproductive Medicine and Fertility	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Time to conception	The amount of time between study randomization and positive pregnancy test.	To be assessed within 6 months of randomization.
Secondary	Participants perceived acceptability	Participants rating of acceptability of the study procedure.	The survey assessing this outcome is completed by the participant on the day of the study procedure.