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Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial

INTRODUCTION: One potential stressor that can affect preimplantation and postimplantation embryonic growth after in vitro fertilisation (IVF) is the pH of the human embryo culture medium, but no evidence exists to indicate which pH level is optimal for IVF. Based on anecdotal evidence or mouse model...

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Autores principales: Fawzy, Mohamed, Emad, Mai, Wilkinson, Jack, Mansour, Ragaa, Mahran, Ali, Fetih, Ahmed, Abdelrahman, Mohamed, AbdelGhafar, Hazem
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044928/
https://www.ncbi.nlm.nih.gov/pubmed/32024790
http://dx.doi.org/10.1136/bmjopen-2019-034194
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author Fawzy, Mohamed
Emad, Mai
Wilkinson, Jack
Mansour, Ragaa
Mahran, Ali
Fetih, Ahmed
Abdelrahman, Mohamed
AbdelGhafar, Hazem
author_facet Fawzy, Mohamed
Emad, Mai
Wilkinson, Jack
Mansour, Ragaa
Mahran, Ali
Fetih, Ahmed
Abdelrahman, Mohamed
AbdelGhafar, Hazem
author_sort Fawzy, Mohamed
collection PubMed
description INTRODUCTION: One potential stressor that can affect preimplantation and postimplantation embryonic growth after in vitro fertilisation (IVF) is the pH of the human embryo culture medium, but no evidence exists to indicate which pH level is optimal for IVF. Based on anecdotal evidence or mouse models, culture media manufacturers recommend a pH range of 7.2 to 7.4, and IVF laboratories routinely use a pH range of 7.25 to 7.3. Given the lack of randomised trials evaluating the effect of pH on live birth rate after IVF, this trial examines the effect of three different pH levels on the live birth rate. METHODS AND ANALYSIS: This multicentre randomised trial will involve centres specialised in IVF in Egypt. Eligible couples for intracytoplasmic sperm injection (ICSI) will be randomised for embryo culture at pH 7.2, 7.3 or 7.4. The study is designed to detect 10 percentage points difference in live birth rate between the best and worst performing media with 93% power at a 1% significance level. The primary outcome is the rate of live birth (delivery of one or more viable infants beyond the 20th week of gestation) after ICSI. Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation). Embryo development outcomes include fertilisation, blastocyst formation and quality, and embryo cryopreservation and utilisation. ETHICS AND DISSEMINATION: The study was reviewed and approved by the Ethics Review Boards of the participating centres. Eligible women will sign a written informed consent before enrolment. This study has an independent data monitoring and safety committee comprised international experts in trial design and in vitro culture. No plan exists to disseminate results to participants or health communities, except for the independent monitoring and safety committee of the trial. TRIAL REGISTRATION NUMBER: NCT02896777.
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spelling pubmed-70449282020-03-09 Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial Fawzy, Mohamed Emad, Mai Wilkinson, Jack Mansour, Ragaa Mahran, Ali Fetih, Ahmed Abdelrahman, Mohamed AbdelGhafar, Hazem BMJ Open Obstetrics and Gynaecology INTRODUCTION: One potential stressor that can affect preimplantation and postimplantation embryonic growth after in vitro fertilisation (IVF) is the pH of the human embryo culture medium, but no evidence exists to indicate which pH level is optimal for IVF. Based on anecdotal evidence or mouse models, culture media manufacturers recommend a pH range of 7.2 to 7.4, and IVF laboratories routinely use a pH range of 7.25 to 7.3. Given the lack of randomised trials evaluating the effect of pH on live birth rate after IVF, this trial examines the effect of three different pH levels on the live birth rate. METHODS AND ANALYSIS: This multicentre randomised trial will involve centres specialised in IVF in Egypt. Eligible couples for intracytoplasmic sperm injection (ICSI) will be randomised for embryo culture at pH 7.2, 7.3 or 7.4. The study is designed to detect 10 percentage points difference in live birth rate between the best and worst performing media with 93% power at a 1% significance level. The primary outcome is the rate of live birth (delivery of one or more viable infants beyond the 20th week of gestation) after ICSI. Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation). Embryo development outcomes include fertilisation, blastocyst formation and quality, and embryo cryopreservation and utilisation. ETHICS AND DISSEMINATION: The study was reviewed and approved by the Ethics Review Boards of the participating centres. Eligible women will sign a written informed consent before enrolment. This study has an independent data monitoring and safety committee comprised international experts in trial design and in vitro culture. No plan exists to disseminate results to participants or health communities, except for the independent monitoring and safety committee of the trial. TRIAL REGISTRATION NUMBER: NCT02896777. BMJ Publishing Group 2020-02-04 /pmc/articles/PMC7044928/ /pubmed/32024790 http://dx.doi.org/10.1136/bmjopen-2019-034194 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Obstetrics and Gynaecology
Fawzy, Mohamed
Emad, Mai
Wilkinson, Jack
Mansour, Ragaa
Mahran, Ali
Fetih, Ahmed
Abdelrahman, Mohamed
AbdelGhafar, Hazem
Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial
title Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial
title_full Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial
title_fullStr Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial
title_full_unstemmed Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial
title_short Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial
title_sort triple-arm trial of ph (tri-ph) effect on live birth after icsi in egyptian ivf facilities: protocol of a randomised controlled trial
topic Obstetrics and Gynaecology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044928/
https://www.ncbi.nlm.nih.gov/pubmed/32024790
http://dx.doi.org/10.1136/bmjopen-2019-034194
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