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AzTrials

EMBRYO IMPLANTATIONNCT03108157

Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF

A study testing Endometrial scratch in people with EMBRYO IMPLANTATION, run by Procreatec at 1 site in Spain.

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

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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
EMBRYO IMPLANTATION
What is being tested?
Endometrial scratch
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteSpain
Study dates
12 Jan 2017to 31 Dec 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female undergoing IVF treatment with donor eggs

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Procreatec

    Madrid, 28036

Other trials in Spain

About this study

Official title: Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF

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.

Read the detailed 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.

Being tested
Endometrial scratch
Keywords
IVF, DONOR EGGS, ENDOMETRIAL SCRATCH, PIPELLE, ONGOING PREGNANCY

What participants receive

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

  • Endometrial scratchProcedure or surgery

    Also called Scratching

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

Study groups in NCT03108157
Study groupRoleWhat they receive
GROUP A: intervention groupExperimentalPatients 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.
Receives: Procedure: Endometrial scratch
GROUP B: no intervention groupNo interventionPatients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.

What is being measured

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

  1. Positive Pregnancy Test

    Positive test (hcG>10 UI/ml)

    Measured: 12 to 14 days after embryo transfer

  2. Clinical Pregnancy

    Ultrasound confirmation of intrauterine pregnancy

    Measured: 5 weeks of pregnancy

Secondary outcomes (1)

  1. Live Birth

    Birth after 24 weeks of pregnancy

    Measured: Pregnancy beyond 24 weeks

Timeline

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

  1. First posted11 Apr 2017
  2. Study start12 Jan 2017
  3. Primary completion30 Nov 2018
  4. Study completion31 Dec 2019

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
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03108157
Sponsor's protocol ID
ENDOSCRATCH
Status last verified
Jun 2020
First submitted
5 Apr 2017
Last updated
23 Jun 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25064410

  • 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.

    PubMed 23063812

  • 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.

    PubMed 25803542

  • 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.

    PubMed 25561347

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

    PubMed 26950730

  • 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.

    PubMed 26752857

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

    PubMed 24100512

  • 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.

    PubMed 25663163

  • 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.

    PubMed 25644507

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

    PubMed 25473625

  • 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.

    PubMed 25349438

  • 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.

    PubMed 27121007

  • 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

  • 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

  • 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.

    PubMed 25316455

Questions about this trial

What is this clinical trial studying?

A study testing Endometrial scratch in people with EMBRYO IMPLANTATION, run by Procreatec at 1 site in Spain.

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 1 inclusion and 2 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 23 Jun 2020. 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 Spain. 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?

Yes. Results are posted in the registry (first posted 4 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Positive Pregnancy Test (time frame: 12 to 14 days after embryo transfer). The study lists 2 primary outcomes in all. 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 NCT03108157, which also lists 20 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 23 Jun 2020.

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