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Completed

NCT Number: NCT03828786

Uterine Scratching in Intra-Uterine Insemination

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.

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Key information

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endometrial scratching

Procedure

Endometrial Biopsy by aspiration with a pipelle

Other names: Endometrial Biopsy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Efficacy - Secondary pregnancy rate.

    Time frame: 6 months

    Ongoing pregnancy during the first trimester ultrasound in the 3 IUI cycles following a scratching

  2. Safety - Side effects

    Time frame: 6 months for all 3 intrauterine insemination

    Evaluate side effects related to the intrauterine scratching

  3. Safety - Complications

    Time frame: 6 months for all 3 intrauterine insemination

    Evaluate complications related to intrauterine scratching

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Feb 4, 2019
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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