Cargando…
The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS
Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian stimulation. The use of gonadotropin releasing hormone (GnRH) agonist for the trigger of oocyte maturation is effective in the prevention of OHSS although it may result in a lower pregnancy rate. The use of...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5898565/ https://www.ncbi.nlm.nih.gov/pubmed/29696192 http://dx.doi.org/10.1016/j.conctc.2017.08.008 |
_version_ | 1783314148632821760 |
---|---|
author | Griffin, Daniel Benadiva, Claudio Budinetz, Tara Sueldo, Carolina DiLuigi, Andrea Nulsen, John Engmann, Lawrence |
author_facet | Griffin, Daniel Benadiva, Claudio Budinetz, Tara Sueldo, Carolina DiLuigi, Andrea Nulsen, John Engmann, Lawrence |
author_sort | Griffin, Daniel |
collection | PubMed |
description | Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian stimulation. The use of gonadotropin releasing hormone (GnRH) agonist for the trigger of oocyte maturation is effective in the prevention of OHSS although it may result in a lower pregnancy rate. The use of adjuvant low dose human chorionic gonadotropin (hCG) at the time of trigger or at the time of oocyte retrieval may improve pregnancy rates. The goal of this dual trigger study is to evaluate the safety and efficacy of the use of low dose hCG administered at the time of GnRH agonist trigger or 35 h later as well as the potential impact on pregnancy rates. The population will consist of 82 women undergoing IVF treatment who are at risk of developing OHSS. This study will be a single center prospective randomized double-blind placebo controlled trial. The randomization schedule will be administered by the Investigational Drug Services of the University. After controlled ovarian stimulation, induction of oocyte maturation will be achieved using a GnRH agonist and patients will be randomized to receive either low dose hCG 1000 IU at the time of trigger and placebo at oocyte retrieval (Study group) or placebo at the time of trigger and hCG 1500 IU at the time of oocyte retrieval (Control group). The main outcomes will be live birth rates and incidence of OHSS. Two ancillary studies will include a quality of life survey and serum assessment of independent corpus luteum function. |
format | Online Article Text |
id | pubmed-5898565 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-58985652018-04-25 The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS Griffin, Daniel Benadiva, Claudio Budinetz, Tara Sueldo, Carolina DiLuigi, Andrea Nulsen, John Engmann, Lawrence Contemp Clin Trials Commun Article Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian stimulation. The use of gonadotropin releasing hormone (GnRH) agonist for the trigger of oocyte maturation is effective in the prevention of OHSS although it may result in a lower pregnancy rate. The use of adjuvant low dose human chorionic gonadotropin (hCG) at the time of trigger or at the time of oocyte retrieval may improve pregnancy rates. The goal of this dual trigger study is to evaluate the safety and efficacy of the use of low dose hCG administered at the time of GnRH agonist trigger or 35 h later as well as the potential impact on pregnancy rates. The population will consist of 82 women undergoing IVF treatment who are at risk of developing OHSS. This study will be a single center prospective randomized double-blind placebo controlled trial. The randomization schedule will be administered by the Investigational Drug Services of the University. After controlled ovarian stimulation, induction of oocyte maturation will be achieved using a GnRH agonist and patients will be randomized to receive either low dose hCG 1000 IU at the time of trigger and placebo at oocyte retrieval (Study group) or placebo at the time of trigger and hCG 1500 IU at the time of oocyte retrieval (Control group). The main outcomes will be live birth rates and incidence of OHSS. Two ancillary studies will include a quality of life survey and serum assessment of independent corpus luteum function. Elsevier 2017-08-17 /pmc/articles/PMC5898565/ /pubmed/29696192 http://dx.doi.org/10.1016/j.conctc.2017.08.008 Text en © 2017 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article Griffin, Daniel Benadiva, Claudio Budinetz, Tara Sueldo, Carolina DiLuigi, Andrea Nulsen, John Engmann, Lawrence The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS |
title | The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS |
title_full | The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS |
title_fullStr | The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS |
title_full_unstemmed | The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS |
title_short | The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS |
title_sort | dual trigger study: rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hcg at the time of gnrh agonist trigger or 35 h later for the prevention of ohss |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5898565/ https://www.ncbi.nlm.nih.gov/pubmed/29696192 http://dx.doi.org/10.1016/j.conctc.2017.08.008 |
work_keys_str_mv | AT griffindaniel thedualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT benadivaclaudio thedualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT budinetztara thedualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT sueldocarolina thedualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT diluigiandrea thedualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT nulsenjohn thedualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT engmannlawrence thedualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT griffindaniel dualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT benadivaclaudio dualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT budinetztara dualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT sueldocarolina dualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT diluigiandrea dualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT nulsenjohn dualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss AT engmannlawrence dualtriggerstudyrationaleandstudydesignofaprospectivedoubleblindrandomizedclinicaltrialcomparingpregnancyratesaftercoadministrationoflowdosehcgatthetimeofgnrhagonisttriggeror35hlaterforthepreventionofohss |