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| Name | Class |
|---|---|
| Hospital Universitario 12 de Octubre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| GROUP B: no intervention group | No Intervention | Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial scratch | Procedure | Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth | Birth after 24 weeks of pregnancy | Pregnancy beyond 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Galindo, PhD | Hospital Universitario 12 Octubre | Study Director |
| Laura De la Fuente, PhD | Hospital Universitario 12 Octubre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Procreatec | Madrid | 28036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25064410 | Background | 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. | |
| 23063812 | Background | 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. |
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Recruitment started on January 2017 and finished in October 2018. All patients were recruited at ProcreaTec Fertility Clinic in Madrid
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| ID | Title | Description |
|---|---|---|
| FG000 | GROUP A: Intervention Group | 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. |
| FG001 | GROUP B: no Intervention Group | Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GROUP A: Intervention Group | 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. |
| BG001 | GROUP B: Non Intervention Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Pregnancy Test | Positive test (hcG>10 UI/ml) | Posted | Count of Participants | Participants | 12 to 14 days after embryo transfer |
|
Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization.
All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed.
We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GROUP A: Intervention Group | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Pregnancy loss before 12th week of gestation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandra Izquierdo, Medical and Scientific Director at ProcreaTec | ProcreaTec | 0034651879266 | endoscratchtrial@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2019 | Aug 8, 2019 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 12, 2017 | May 30, 2020 | Prot_002.pdf |
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|
| 25803542 | Background | 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. |
| 25561347 | Background | 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. |
| 26950730 | Background | Ko JK, Ng EH. Scratching and IVF: any role? Curr Opin Obstet Gynecol. 2016 Jun;28(3):178-83. doi: 10.1097/GCO.0000000000000264. |
| 26752857 | Background | 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. |
| 24100512 | Background | Wise J. Endometrial scratching improves IVF pregnancy rate. BMJ. 2013 Oct 4;347:f6007. doi: 10.1136/bmj.f6007. No abstract available. |
| 25663163 | Background | 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. |
| 25644507 | Background | 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. |
| 25473625 | Background | Timeva T, Shterev A, Kyurkchiev S. Recurrent implantation failure: the role of the endometrium. J Reprod Infertil. 2014 Oct;15(4):173-83. |
| 25349438 | Background | 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. |
| 27121007 | Background | 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. |
| 27008891 | 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. |
| 20070722 | 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. |
| 25316455 | Background | 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. |
| 26218557 | Background | 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. |
| 26890618 | Background | 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. |
| 23754314 | Background | 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. |
| 32473654 | Derived | 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. |
| 32468267 | Derived | 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. |
Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Smokers | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Clinical Pregnancy | Ultrasound confirmation of intrauterine pregnancy | Posted | Count of Participants | Participants | 5 weeks of pregnancy |
|
|
|
| Secondary | Live Birth | Birth after 24 weeks of pregnancy | Posted | Count of Participants | Participants | Pregnancy beyond 24 weeks |
|
|
|
| 0 |
| 161 |
| 0 |
| 161 |
| 36 |
| 161 |
| EG001 | GROUP B: no Intervention Group | Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment. | 0 | 172 | 0 | 172 | 47 | 172 |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Extrauterine evidence of pregnancy |
|
| Vanishing twin | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Second twin arrest before week 12th of gestation |
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| Placentation abnormalities | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Alterations in placental development (accretism, percretism...) |
|
| Intrauterine growth restriction | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Pathological decrease in the growth of the fetus |
|
| Preterm delivery threat | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Menace of preterm before the 37th week of gestation |
|
| Premature membrane rupture | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Rupture of gestational membranes before the 37th week of pregnancy. |
|
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Presence of a diabetical status in a pregnant woman who was not previously diabetic |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Gestational hypertension and proteinuria |
|
| Gestational cholestasis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Biliary acid alteration due to gestational status |
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| Abortion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Voluntary interruption of gestation |
|
| Preterm delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Delivery before the 37th week of pregnancy |
|
| 2nd twin stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Intrauterine death of the 2nd twin before delivery |
|
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