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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03108157
Other study ID # ENDOSCRATCH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 12, 2017
Est. completion date December 31, 2019

Study information

Verified date June 2020
Source Procreatec
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The aim of this clinical trial is to investigate whether an endometrial scratch during the cycle prior to embryo transfer cycle is effective or not in increasing pregnancy rates. Previous studies about this issue have not shown clear conclusions about the effectiveness of this method.

The endometrial scratch is a simple technique that consists in performing a mild injury to all the internal walls of the uterus with a Pipelle Cournier.

To achieve the trial objective, all participating patients are randomly divided into two groups. Once patients decide to participate in the trial, they are assigned to each group according to the randomization list:

Group A: Patients with transfer of fresh embryos after taking an endometrium biopsy during the previous cycle and then following the conventional preparation protocol.

Group B: Patients with transfer of fresh embryos with the conventional preparation protocol.


Recruitment information / eligibility

Status Completed
Enrollment 352
Est. completion date December 31, 2019
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Female undergoing IVF treatment with donor eggs

Exclusion Criteria:

- Severe male factor ( less tan 2 million spermatozoa per ml )

- Uterine abnormalities

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Procreatec Madrid

Sponsors (2)

Lead Sponsor Collaborator
Procreatec Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

Wise J. Endometrial scratching improves IVF pregnancy rate. BMJ. 2013 Oct 4;347:f6007. doi: 10.1136/bmj.f6007. — View Citation

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. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Positive Pregnancy Test Positive test (hcG>10 UI/ml) 12 to 14 days after embryo transfer
Primary Clinical Pregnancy Ultrasound confirmation of intrauterine pregnancy 5 weeks of pregnancy
Secondary Live Birth Birth after 24 weeks of pregnancy Pregnancy beyond 24 weeks
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