Uterine Scratching in Intra-Uterine Insemination

Not Applicable

Completed

• Conditions: Infertility; Unexplained Infertility
• Interventions: Procedure: Endometrial scratching

• Registration Number: NCT03828786
• Lead Sponsor: Clinique Ovo

Brief Summary

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.

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 Timeline

• Study Start: 2018-07-15
• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Primary Completion: 2023-03-31
• Study Completion: 2024-03-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 394

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endometrial scratching group	Endometrial scratching	Endometrial scratching will be done with a Pipelle in uterus.

Primary Outcome Measures

Name	Time	Method
Efficacy - Pregnancy Rate measured during the first trimester ultrasound.	13 weeks	Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montreal, Quebec, Canada