Uterine Scratching in Intra-Uterine Insemination

NCT03828786 | Completed

• 1 other identifier: ovo-18-01
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Unexplained Infertility

Keywords

intra-uterine insemination; endometrial injury; scratching

Outcome Measures

Primary Outcomes (1)

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

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

  13 weeks

Secondary Outcomes (3)

• Efficacy - Secondary pregnancy rate.

  6 months

• Safety - Side effects

  6 months for all 3 intrauterine insemination

• Safety - Complications

  6 months for all 3 intrauterine insemination

Study Arms (2)

Endometrial scratching group

ACTIVE COMPARATOR

Endometrial scratching will be done with a Pipelle in uterus.

Procedure: Endometrial scratching

Control group

NO INTERVENTION

This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure

Interventions

Endometrial scratching PROCEDURE

Endometrial Biopsy by aspiration with a pipelle

Also known as: Endometrial Biopsy

Endometrial scratching group

Eligibility Criteria

• Age: 18 Years - 41 Years
• Gender Eligibility Details: Women of reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Related Publications (16)

• 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.

  PMID: 17681303 BACKGROUND

• 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.

  PMID: 26538858 BACKGROUND

• 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.

  PMID: 17197286 BACKGROUND

• 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.

  PMID: 23095139 BACKGROUND

• 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.

  PMID: 22786529 BACKGROUND

• 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.

  PMID: 20607003 BACKGROUND

• 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.

  PMID: 26342054 BACKGROUND

• 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.

  PMID: 27296541 BACKGROUND

• 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.

  PMID: 27008891 BACKGROUND

• 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.

  PMID: 26777262 BACKGROUND

• 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.

  PMID: 20070722 BACKGROUND

• 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.

  PMID: 23106834 BACKGROUND

• 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.

  PMID: 5050152 BACKGROUND

• 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.

  PMID: 12798877 BACKGROUND

• 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.

  PMID: 27146582 BACKGROUND

• Abdelhamid AM. The success rate of pregnancy in IUI cycles following endometrial sampling. A randomized controlled study: endometrial sampling and pregnancy rates. Arch Gynecol Obstet. 2013 Sep;288(3):673-8. doi: 10.1007/s00404-013-2785-0. Epub 2013 Mar 15.

  PMID: 23494199 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Louise Lapensee, Md

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: February 4, 2019
• Study Start: July 15, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 30, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)