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Uterine Scratching in Intra-Uterine Insemination

Sponsor
Clinique Ovo (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03828786
Collaborator
(none)
394
Enrollment
1
Location
2
Arms
53
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endometrial scratching
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
394 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact of Uterine Scratching Prior to Intra-Uterine Insemination in Unexplained Infertility, a Randomized Controlled Trial
Actual Study Start Date :
Jul 15, 2018
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Efficacy - Secondary pregnancy rate. [6 months]

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

    2. Safety - Side effects [6 months for all 3 intrauterine insemination]

      Evaluate side effects related to the intrauterine scratching

    3. Safety - Complications [6 months for all 3 intrauterine insemination]

      Evaluate complications related to intrauterine scratching

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 41 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Ovo Montreal Quebec Canada H4P 2S4

    Sponsors and Collaborators

    • Clinique Ovo

    Investigators

    • Principal Investigator: Louise Lapensee, Md, Clinique Ovo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Clinique Ovo
    ClinicalTrials.gov Identifier:
    NCT03828786
    Other Study ID Numbers:
    • ovo-18-01
    First Posted:
    Feb 4, 2019
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Clinique Ovo
    intra-uterine insemination
    endometrial injury
    scratching
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Jan 11, 2022