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Griffin D, Benadiva C, Budinetz T, et al. 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. Contemp Clin Trials Commun. 2017;8:18-24doi: 10.1016/j.conctc.2017.08.008.
Griffin, D., Benadiva, C., Budinetz, T., Sueldo, C., DiLuigi, A., Nulsen, J., & Engmann, L. (2017). 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. Contemporary clinical trials communications, 818-24. https://doi.org/10.1016/j.conctc.2017.08.008
Griffin, Daniel, et al. "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." Contemporary clinical trials communications vol. 8 (2017): 18-24. doi: https://doi.org/10.1016/j.conctc.2017.08.008
Griffin D, Benadiva C, Budinetz T, Sueldo C, DiLuigi A, Nulsen J, Engmann L. 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. Contemp Clin Trials Commun. 2017 Aug 17;8:18-24. doi: 10.1016/j.conctc.2017.08.008. eCollection 2017 Dec. PMID: 29696192; PMCID: PMC5898565.
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Contemp Clin Trials Commun. 2017 Aug 17;8:18-24. doi: 10.1016/j.conctc.2017.08.008. eCollection 2017 Dec.

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.

Contemporary clinical trials communications

Daniel Griffin, Claudio Benadiva, Tara Budinetz, Carolina Sueldo, Andrea DiLuigi, John Nulsen, Lawrence Engmann

Affiliations

  1. Department of Obstetrics and Gynecology, Center for Advanced Reproductive Services, University of Connecticut School of Medicine, USA.

PMID: 29696192 PMCID: PMC5898565 DOI: 10.1016/j.conctc.2017.08.008

Abstract

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.

Keywords: Dual trigger; GnRH agonist trigger; IVF; Low dose hCG; OHSS; PCOS

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