Uterine Scratching in Intra-Uterine Insemination

March 17, 2025 updated by: Clinique Ovo

The Impact of Uterine Scratching Prior to Intra-Uterine Insemination in Unexplained Infertility, a Randomized Controlled Trial

This study will evaluate the potential benefits of uterine injury during the follicular phase of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first trimester ultrasound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infertility is defined as the absence of conception after a year of unprotected intercourse. In 10 to 30 % of patients, the cause of the infertility is unknown. An emerging practice in unexplained infertility has been to cause a uterine trauma prior to treatment. This is done by doing a small endometrial scratch with a pipelle. This intervention has been study in IVF and has been shown beneficial. Theoretically, the uterine scratching could increase the immune response and the vascularization of the endometrium which could help in embryo implantation. However, there is very few data concerning scratching in intrauterine insemination. The studies are mostly small studies and the results are often contradictory. In this randomized controlled trial, the investigators will evaluate the effect of uterine scratching during the follicular phase of an insemination cycle on the pregnancy rate of a large cohort of unexplained infertile couples.

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
        • Clinique ovo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 41 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above.
  • At least one permeable tube on hysterosonography or hysterosalpingography within the last 2 years or vaginal delivery in the last 3 years.
  • Antral follicular count over 5.
  • Normal or mild male factor.
  • Normal uterine cavity.
  • An IUI prescription.

Exclusion Criteria:

  • Polycystic ovary syndrome with irregular menstrual cycles over 45 days
  • Severe endometriosis
  • IUI with Donor sperm
  • Patient with invasive intra-uterine procedure in the last 3 months.
  • Contraindication to endometrial biopsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endometrial scratching group
Endometrial scratching will be done with a Pipelle in uterus.
Procedure: Endometrial scratching
Endometrial Biopsy by aspiration with a pipelle
Other Names:
  • Endometrial Biopsy
No Intervention: Control group
This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Pregnancy Rate measured during the first trimester ultrasound.
Time Frame: 13 weeks
Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle.
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Secondary pregnancy rate.
Time Frame: 6 months
Ongoing pregnancy during the first trimester ultrasound in the 3 IUI cycles following a scratching
6 months
Safety - Side effects
Time Frame: 6 months for all 3 intrauterine insemination
Evaluate side effects related to the intrauterine scratching
6 months for all 3 intrauterine insemination
Safety - Complications
Time Frame: 6 months for all 3 intrauterine insemination
Evaluate complications related to intrauterine scratching
6 months for all 3 intrauterine insemination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Ovo

Investigators

  • Principal Investigator: Louise Lapensée, MD, Clinique ovo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2018

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 30, 2024

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ovo-18-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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