NCT03108157

Brief Summary

Clinical trial about the effect of endometrial scratch on pregnancy rates in patients undergoing a treatment with in-vitro fertilization with donor eggs, when doing the endometrial biopsy during the cycle prior to the embryo transfer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 4, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

April 5, 2017

Results QC Date

August 8, 2019

Last Update Submit

June 10, 2020

Conditions

EMBRYO IMPLANTATION

Keywords

IVFDONOR EGGSENDOMETRIAL SCRATCHPIPELLEONGOING PREGNANCY

Outcome Measures

Primary Outcomes (2)

  • Positive Pregnancy Test

    Positive test (hcG\>10 UI/ml)

    12 to 14 days after embryo transfer

  • Clinical Pregnancy

    Ultrasound confirmation of intrauterine pregnancy

    5 weeks of pregnancy

Secondary Outcomes (1)

  • Live Birth

    Pregnancy beyond 24 weeks

Study Arms (2)

GROUP A: intervention group

EXPERIMENTAL

Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.

Procedure: Endometrial scratch

GROUP B: no intervention group

NO INTERVENTION

Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.

Interventions

Endometrial scratchPROCEDURE

Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.

Also known as: Scratching
GROUP A: intervention group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female undergoing IVF treatment with donor eggs

You may not qualify if:

  • Severe male factor ( less tan 2 million spermatozoa per ml )
  • Uterine abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Procreatec

Madrid, 28036, Spain

Location

Related Publications (20)

  • Dain L, Ojha K, Bider D, Levron J, Zinchenko V, Walster S, Dirnfeld M. Effect of local endometrial injury on pregnancy outcomes in ovum donation cycles. Fertil Steril. 2014 Oct;102(4):1048-54. doi: 10.1016/j.fertnstert.2014.06.044. Epub 2014 Jul 23.

    PMID: 25064410BACKGROUND

  • Potdar N, Gelbaya T, Nardo LG. Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Dec;25(6):561-71. doi: 10.1016/j.rbmo.2012.08.005. Epub 2012 Sep 12.

    PMID: 23063812BACKGROUND

  • Nastri CO, Lensen SF, Gibreel A, Raine-Fenning N, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2015 Mar 22;(3):CD009517. doi: 10.1002/14651858.CD009517.pub3.

    PMID: 25803542BACKGROUND

  • Gibreel A, El-Adawi N, Elgindy E, Al-Inany H, Allakany N, Tournaye H. Endometrial scratching for women with previous IVF failure undergoing IVF treatment. Gynecol Endocrinol. 2015 Apr;31(4):313-6. doi: 10.3109/09513590.2014.994603. Epub 2015 Jan 5.

    PMID: 25561347BACKGROUND

  • Ko JK, Ng EH. Scratching and IVF: any role? Curr Opin Obstet Gynecol. 2016 Jun;28(3):178-83. doi: 10.1097/GCO.0000000000000264.

    PMID: 26950730BACKGROUND

  • Singh N, Toshyan V, Kumar S, Vanamail P, Madhu M. Does endometrial injury enhances implantation in recurrent in-vitro fertilization failures? A prospective randomized control study from tertiary care center. J Hum Reprod Sci. 2015 Oct-Dec;8(4):218-23. doi: 10.4103/0974-1208.170401.

    PMID: 26752857BACKGROUND

  • Wise J. Endometrial scratching improves IVF pregnancy rate. BMJ. 2013 Oct 4;347:f6007. doi: 10.1136/bmj.f6007. No abstract available.

    PMID: 24100512BACKGROUND

  • Yang R, Yang S, Li R, Chen X, Wang H, Ma C, Liu P, Qiao J. Biochemical pregnancy and spontaneous abortion in first IVF cycles are negative predictors for subsequent cycles: an over 10,000 cases cohort study. Arch Gynecol Obstet. 2015 Aug;292(2):453-8. doi: 10.1007/s00404-015-3639-8. Epub 2015 Feb 8.

    PMID: 25663163BACKGROUND

  • Ueno J, Salgado RM, Tomioka RB, Colucci JA, Schor E, Carvalho FM. Clinical relevance of diagnostic hysteroscopy with concurrent endometrial biopsy in the accurate assessment of intrauterine alterations. Arch Gynecol Obstet. 2015 Aug;292(2):363-9. doi: 10.1007/s00404-015-3634-0. Epub 2015 Feb 3.

    PMID: 25644507BACKGROUND

  • Timeva T, Shterev A, Kyurkchiev S. Recurrent implantation failure: the role of the endometrium. J Reprod Infertil. 2014 Oct;15(4):173-83.

    PMID: 25473625BACKGROUND

  • Gnainsky Y, Granot I, Aldo P, Barash A, Or Y, Mor G, Dekel N. Biopsy-induced inflammatory conditions improve endometrial receptivity: the mechanism of action. Reproduction. 2015 Jan;149(1):75-85. doi: 10.1530/REP-14-0395. Epub 2014 Oct 27.

    PMID: 25349438BACKGROUND

  • Lensen S, Martins W, Nastri C, Sadler L, Farquhar C. Pipelle for Pregnancy (PIP): study protocols for three randomised controlled trials. Trials. 2016 Apr 27;17(1):216. doi: 10.1186/s13063-016-1301-9.

    PMID: 27121007BACKGROUND

  • 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: 27008891BACKGROUND

  • 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: 20070722BACKGROUND

  • Nastri CO, Polanski LT, Raine-Fenning N, Martins WP. Endometrial scratching for women with repeated implantation failure. Hum Reprod. 2014 Dec;29(12):2855-6. doi: 10.1093/humrep/deu257. Epub 2014 Oct 14. No abstract available.

    PMID: 25316455BACKGROUND

  • Panagiotopoulou N, Karavolos S, Choudhary M. Endometrial injury prior to assisted reproductive techniques for recurrent implantation failure: a systematic literature review. Eur J Obstet Gynecol Reprod Biol. 2015 Oct;193:27-33. doi: 10.1016/j.ejogrb.2015.06.026. Epub 2015 Jul 17.

    PMID: 26218557BACKGROUND

  • Kitaya K, Matsubayashi H, Takaya Y, Nishiyama R, Yamaguchi K, Ishikawa T. Clinical background affecting pregnancy outcome following local endometrial injury in infertile patients with repeated implantation failure. Gynecol Endocrinol. 2016 Jul;32(7):587-90. doi: 10.3109/09513590.2016.1144742. Epub 2016 Feb 18.

    PMID: 26890618BACKGROUND

  • Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.

    PMID: 23754314BACKGROUND

  • Izquierdo A, de la Fuente L, Spies K, Rayward J, Lopez L, Lora D, Galindo A. Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol. BMC Pregnancy Childbirth. 2020 May 30;20(1):333. doi: 10.1186/s12884-020-02958-0.

    PMID: 32473654DERIVED

  • Izquierdo Rodriguez A, de la Fuente Bitaine L, Spies K, Lora D, Galindo A. Endometrial Scratching Effect on Clinical Pregnancy Rates in Patients Undergoing Egg Donor In Vitro Fertilization Cycles: the ENDOSCRATCH Randomized Clinical Trial (NCT03108157). Reprod Sci. 2020 Oct;27(10):1863-1872. doi: 10.1007/s43032-020-00204-8. Epub 2020 May 28.

    PMID: 32468267DERIVED

Results Point of Contact

Title
Dr. Alexandra Izquierdo, Medical and Scientific Director at ProcreaTec
Organization
ProcreaTec
endoscratchtrial@gmail.com
0034651879266

Study Officials

  • Alberto Galindo, PhD

    Hospital Universitario 12 Octubre

    STUDY DIRECTOR

  • Laura De la Fuente, PhD

    Hospital Universitario 12 Octubre

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

January 12, 2017

Primary Completion

November 30, 2018

Study Completion

December 31, 2019

Last Updated

June 23, 2020

Results First Posted

December 4, 2019

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)