GnRH Agonist and hCG (Dual Trigger) Versus hCG Trigger for Final Oocyte Maturation in Expected Normal Responders With a High Immature Oocyte Rate: Study Protocol for a Randomized, Superiority, Parallel Group, Controlled Trial

• Published in: Frontiers in endocrinology (Lausanne) 2022-03, Vol.13, p.831859-831859
• Main Authors: Yan, Meng-Han, Cao, Jing-Xian, Hou, Jin-Wei, Jiang, Wen-Jing, Wang, Dan-Dan, Sun, Zhen-Gao, Song, Jing-Yan
• Format: Article
• Language: English
• Subjects: Chorionic Gonadotropin; dual trigger; Endocrinology; Female; gonadotropin releasing hormone agonist; Gonadotropin-Releasing Hormone; human chorionic gonadotropin; Humans; in vitro fertilization/intracytoplasmic sperm injection; normal ovarian responder; Oocytes; Ovarian Hyperstimulation Syndrome - epidemiology; Ovarian Hyperstimulation Syndrome - prevention & control; Ovulation Induction - methods; Pregnancy; Randomized Controlled Trials as Topic; Recombinant Proteins
• ISSN: 1664-2392; 1664-2392
• DOI: 10.3389/fendo.2022.831859

The choice of trigger drug for the controlled ovarian hyperstimulation (COH) protocol correlates with the outcome of fertilization/intracytoplasmic sperm injection embryo transfer (IVF/ICSI-ET). The co-administration of gonadotropin releasing hormone agonist (GnRH-a) and human chorionic gonadotropin (hCG), i.e., dual trigger, for final oocyte maturation, has received much attention in recent years. This trial was designed to determine whether a dual trigger approach by lengthening the time between trigger and ovum pick-up (OPU) improves the quantity and quality of mature oocytes/top-quality embryos and pregnancy outcomes in expected normal responders with a high immature oocyte rate. We propose a study at the Affiliated Hospital of Shandong University of Chinese Medicine. A total of 90 individuals undergoing COH use a fixed GnRH antagonist protocol. They will be assigned randomly into two groups according to the trigger method and timing: recombinant hCG (6500 IU) will be injected only 36 hours before OPU for final oocyte maturation (hCG-only trigger); co-administration of GnRH-a and hCG for final oocyte maturation, 40 and 34 hours prior to OPU, respectively (Dual trigger). The primary outcome is metaphase-II (MII) oocytes rate. Secondary outcomes are number of oocytes retrieved, fertilization rate, top-quality embryos rate, blastula formation rate, embryo implantation rate, clinical pregnancy rate, miscarriage rate, live birth rate, cumulative pregnancy/live birth rates, and ovarian hyperstimulation syndrome (OHSS) rate. The reproductive ethics committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine certified this study (Identifier: SDUTCM/2021.7.26) as ethical. All individuals will sign written informed consent. All data and biological samples will be protected according to law. The results of this study will be disseminated in a peer-reviewed scientific journal. [chictr.gov.cn], identifier [ChiCTR2100049292].