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InfertilityNCT03828786

Uterine Scratching in Intra-Uterine Insemination

A study testing Endometrial scratching in people with Infertility and Unexplained Infertility, run by Clinique Ovo at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 41 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Unexplained Infertility
What is being tested?
Endometrial scratching
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
394 participants
Where
1 siteCanada
Study dates
15 Jul 2018to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 41 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Clinique Ovo

    Montreal, Quebec, H4P 2S4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Endometrial scratching
Keywords
intra-uterine insemination, endometrial injury, scratching
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endometrial scratchingProcedure or surgery

    Also called Endometrial Biopsy

    Endometrial Biopsy by aspiration with a pipelle

Study groups in NCT03828786
Study groupRoleWhat they receive
Endometrial scratching groupActive comparatorEndometrial scratching will be done with a Pipelle in uterus.
Receives: Procedure: Endometrial scratching
Control groupNo interventionThis group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy - Pregnancy Rate measured during the first trimester ultrasound.

    Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle.

    Measured: 13 weeks

Secondary outcomes (3)

  1. Efficacy - Secondary pregnancy rate.

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

    Measured: 6 months

  2. Safety - Side effects

    Evaluate side effects related to the intrauterine scratching

    Measured: 6 months for all 3 intrauterine insemination

  3. Safety - Complications

    Evaluate complications related to intrauterine scratching

    Measured: 6 months for all 3 intrauterine insemination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start15 Jul 2018
  3. Primary completion31 Mar 2023
  4. Study completion30 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03828786
Sponsor's protocol ID
ovo-18-01
Status last verified
Mar 2025
First submitted
27 Jul 2018
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.

    PubMed 17681303

  • 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.

    PubMed 26538858

  • Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.

    PubMed 17197286

  • Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 Jan;99(1):63. doi: 10.1016/j.fertnstert.2012.09.023. Epub 2012 Oct 22.

    PubMed 23095139

  • Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2.

    PubMed 22786529

  • Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.

    PubMed 20607003

  • Maged AM, Al-Inany H, Salama KM, Souidan II, Abo Ragab HM, Elnassery N. Endometrial Scratch Injury Induces Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation: A Randomized Controlled Trial. Reprod Sci. 2016 Feb;23(2):239-43. doi: 10.1177/1933719115602776. Epub 2015 Sep 3.

    PubMed 26342054

  • Lensen SF, Manders M, Nastri CO, Gibreel A, Martins WP, Templer GE, Farquhar C. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2016 Jun 14;(6):CD011424. doi: 10.1002/14651858.CD011424.pub2.

    PubMed 27296541

  • Lensen S, Sadler L, Farquhar C. Endometrial scratching for subfertility: everyone's doing it. Hum Reprod. 2016 Jun;31(6):1241-4. doi: 10.1093/humrep/dew053. Epub 2016 Mar 22.

    PubMed 27008891

  • Ledee N, Petitbarat M, Chevrier L, Vitoux D, Vezmar K, Rahmati M, Dubanchet S, Gahery H, Bensussan A, Chaouat G. The Uterine Immune Profile May Help Women With Repeated Unexplained Embryo Implantation Failure After In Vitro Fertilization. Am J Reprod Immunol. 2016 Mar;75(3):388-401. doi: 10.1111/aji.12483. Epub 2016 Jan 18.

    PubMed 26777262

  • Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.

    PubMed 20070722

  • Gibreel A, Badawy A, El-Refai W, El-Adawi N. Endometrial scratching to improve pregnancy rate in couples with unexplained subfertility: a randomized controlled trial. J Obstet Gynaecol Res. 2013 Mar;39(3):680-4. doi: 10.1111/j.1447-0756.2012.02016.x. Epub 2012 Oct 29.

    PubMed 23106834

  • Finn CA, Martin L. Endocrine control of the timing of endometrial sensitivity to a decidual stimulus. Biol Reprod. 1972 Aug;7(1):82-6. doi: 10.1093/biolreprod/7.1.82. No abstract available.

    PubMed 5050152

  • Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.

    PubMed 12798877

  • Bahaa Eldin AM, Abdelmaabud KH, Laban M, Hassanin AS, Tharwat AA, Aly TR, Elbohoty AE, Elsayed HM, Ibrahim AM, Ibrahim ME, Sabaa HM, Abdelrazik AA, Abdelhady I. Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination: An Interventional Randomized Clinical Trial. Reprod Sci. 2016 Oct;23(10):1326-31. doi: 10.1177/1933719116638191. Epub 2016 May 4.

    PubMed 27146582

Questions about this trial

What is this clinical trial studying?

A study testing Endometrial scratching in people with Infertility and Unexplained Infertility, run by Clinique Ovo at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy - Pregnancy Rate measured during the first trimester ultrasound. (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03828786, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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