Uterine Scratching in Intra-Uterine Insemination

NCT ID: NCT03828786

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2024-03-30

Brief Summary

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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

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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.

Conditions

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Infertility Unexplained Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endometrial scratching group

Endometrial scratching will be done with a Pipelle in uterus.

Group Type ACTIVE_COMPARATOR

Endometrial scratching

Intervention Type PROCEDURE

Endometrial Biopsy by aspiration with a pipelle

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endometrial scratching

Endometrial Biopsy by aspiration with a pipelle

Intervention Type PROCEDURE

Other Intervention Names

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Endometrial Biopsy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Clinique Ovo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louise Lapensee, Md

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

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Clinique Ovo

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 17681303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26538858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17197286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23095139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22786529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20607003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26342054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27296541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27008891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26777262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20070722 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23106834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5050152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12798877 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27146582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23494199 (View on PubMed)

Other Identifiers

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ovo-18-01

Identifier Type: -

Identifier Source: org_study_id

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