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Endometrial Scratching Effect on Clinical Pregnancy Rates in Patients Undergoing Egg Donor In Vitro Fertilization Cycles: the ENDOSCRATCH Randomized Clinical Trial (NCT03108157)

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Abstract

The potential benefit of endometrial scratching (ES) on embryo implantation is still a controversial subject. At present, the single retrospective study in egg donor IVF cycles concluded that ES has no beneficial effect. Our objective was to determine if there are differences in clinical pregnancy rates (CPR) in egg donor cycles when an ES is performed. This is a randomized controlled trial (RCT) in egg donor IVF patients conducted at ProcreaTec Fertility Center in Madrid. Three hundred fifty-two patients were included in total. One hundred sixty-one patients completed the protocol in group A and 172 patients in group B. Patients allocated to group A received an ES in the luteal phase of the cycle preceding the embryo transfer cycle. Group B patients did not receive any intervention. Primary outcome of this RCT was CPR. Secondary outcomes were implantation (IR), miscarriage (MR), ongoing pregnancy (OPR), multiple pregnancy (MulPR), and live birth rates (LBR). CPR was 104 of 161 (64.6%) in group A and 102 of 172 (59.3%) in group B (RR 1.09, 95% confidence interval (CI) (0.92–1.29); p = 0.378). OPR, MR, MulPR, and LBR were also comparable. No major complications were detected after ES and pregnancy complications were comparable. Our results show that there is no beneficial role of ES in egg donor IVF cycles, considering these patients as the ideal model as they share homogeneous embryo quality and endometrial preparation protocols. This trial was registered on April 5, 2017, as the ENDOSCRATCH trial (NCT03108157).

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Data Availability

All data are stored at ProcreaTec Clinic and available at request.

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Acknowledgments

We would like to acknowledge all clinicians (Jennifer Rayward, MD, Lourdes Lopez, MD, Marta Moschetta, PhD; Rut Gómez de Segura, MD; Maria Calomarde, MD), nurses (Lorena Lopez, Raquel Pascual, Patricia Gonzalez), and patient care personnel (Nathalie Kunsch, Sophie Ortells, Hélène Fortané, Feriel Khelifati, Samantha Ferrigno, Irene Dietrich, Irene Alvarez, Angela Arlotta) involved in this study.

Funding

This work was fully supported by ProcreaTec Fertility Center. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

Authors

Contributions

A.I.R. contributed with the conception of the study protocol, study design, patient recruitment and treatment, data collection and analysis, and manuscript redaction.

L.F.B. contributed to the development of the initial idea, design of the study protocol, data interpretation and manuscript redaction, supervision, and approval.

K.S. contributed with patient recruitment and treatment, data collection, and manuscript approval.

D.L.R. and A.G. contributed with protocol design, data analysis, manuscript redaction, and approval.

Corresponding author

Correspondence to Alexandra Izquierdo Rodriguez.

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Conflicts of Interest

The authors declare that they have no conflict of interest.

Ethical Approval

This study was conducted after the authorization of the Ethical Committee of Princesa Hospital in Madrid (registry no 2934/12-01-2017). Clinical data were treated confidentially following the Spanish data protection law (Spanish Organic Law 15/1999, 13th Dec).

Consent to Participate

All patients included in the study had signed the approved informed consent to participate.

Consent for Publication

All patients included in the study had signed the approved informed consent to allow publication of anonymous data.

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Izquierdo Rodriguez, A., de la Fuente Bitaine, L., Spies, K. et al. Endometrial Scratching Effect on Clinical Pregnancy Rates in Patients Undergoing Egg Donor In Vitro Fertilization Cycles: the ENDOSCRATCH Randomized Clinical Trial (NCT03108157). Reprod. Sci. 27, 1863–1872 (2020). https://doi.org/10.1007/s43032-020-00204-8

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