Effect of laser-assisted zona thinning, during assisted reproduction, on pregnancy outcome in women with endometriosis: randomized controlled trial

Objective To compare the ICSI-ET outcomes in patients with endometriosis with or without laser-assisted zona pellucida thinning. Design Randomized controlled trial. Setting The study was conducted in the Obstetrics & Gynecology Department, Cairo University hospital, and two private IVF centers in Cairo & Beni-Suif from July 2015 to January 2017 upon infertile and known endometriosis patients who planned to do ICSI-ET. Interventions Before randomization, all patients received the same ovarian stimulation preparation, oocyte retrieval procedures, and the same intracytoplasmic sperm injection procedures. After randomization, laser-assisted hatching was performed only for embryos of 158 patients, while the other group (n = 150) no laser-assisted hatching was made. The verification of pregnancy was achieved by the serum hCG concentration 14 days after the embryo transfer, and the clinical pregnancy was confirmed 2 weeks later by the presence of gestational sac with pulsating fetal pole on vaginal ultrasonography. Measurements The main outcome measures were the clinical pregnancy rate and the clinical implantation rate. Main results Both groups were comparable with regard their baseline characteristics, baseline hormonal profile, the ovarian stimulation characteristics, and the ovulation characteristics. The mean number of embryos developed per patient and the mean transferred number of embryos per patient were comparable between groups (p value > 0.05). The implantation rate was significantly higher (p value 0.002) in the study group than the control group with an odds ratio of 1.86 (CI 95% 1.24–2.80) and NNT 13.81 (CI 95% 8.35–39.94). The clinical pregnancy rate, was significantly (p value 0.022) higher in the study group than in the control group with an odds ratio of 1.79 (CI 95% 1.05–3.06) and NNT 9.57 (CI 95% 5.03–98.99).

That laser-assisted hatching by thinning of the zona pellucida may be a suitable method to improve the ICSI-ET outcomes, in term of the implantation and the pregnancy rates, in cases of endometriosis. Clinical trial registration Pan African Clinical Trials Registry (PACTR), http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201502001022393, PACTR201602001467322. Similar content being viewed by others Change history 10 October 2023 An Editorial Expression of Concern to this paper has been published: https://doi.org/10.1007/s00404-023-07236-w

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We would like to acknowledge Dr. Emad R. H. Issak (ClinAmygate) for his efforts in statistical analysis and editing of this manuscript. Author information Authors and Affiliations Contributions AE, HA, AMN, MAB, TT, SS, FH, and EZ contributed to conception of the idea and design. AMN, MAB, FH, and EZ administered the study and collected the data. Validation was performed by AE, HA, MAB, TT, SS, and EZ. Analysis was carried out by AMN, FH, and EZ. AE, HA, AMN, MAB, and FH drafted the manuscript. Revision of the final manuscript was carried out by AE, HA, AMN, MAB, TT, SS, FH, and EZ. Corresponding author Ethics declarations Conflict of interest Adel M. Nada declares that he has no conflict of interest. Amr El-Noury declares that he has no conflict of interest. Hesham Al-Inany declares that he has no conflict of interest. Mamdouh Bibars declares that he has no conflict of interest. Tamer Taha declares that he has no conflict of interest. Sameh Salama declares that he has no conflict of interest. Fatma Hassan declares that she has no conflict of interest. Eman Zein declares that she has no conflict of interest. Funding This research did not receive any specific grant from any funding agency in the public, commercial, or not-for-profit sector. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from all individual participants included in the study. Rights and permissions About this article Cite this article Nada, A.M., El-Noury, A., Al-Inany, H. et al. Effect of laser-assisted zona thinning, during assisted reproduction, on pregnancy outcome in women with endometriosis: randomized controlled trial. Arch Gynecol Obstet 297, 521–528 (2018). https://doi.org/10.1007/s00404-017-4604-5 Received: Accepted: Published: Issue date: DOI: https://doi.org/10.1007/s00404-017-4604-5