NCT03169166

The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective comparative randomized controlled trial investigating the effect of two GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology.

Detailed description

Follicle maturation triggering is the final differentiation process of an immature egg before fertilization, either in normal or stimulated ovarian cycles in assisted reproductive techniques. This step has traditionally been accomplished by the administration of human chorionic gonadotropin (hCG) trigger which mimics LH activity. However, hCG is a primary cause of severe ovarian hyperstimulation syndrome (OHSS) in women and appears to initiate the complex cascade that leads to the development of serious medical complications. Numerous strategies have been suggested to prevent OHSS; one of these is the administration of a gonadotropin releasing hormone (GnRH) agonist trigger instead of hCG. Despite a high safety profile, the GnRH agonist trigger of follicle maturation was found to be associated with a decreased probability of clinical and ongoing pregnancy rates and very high miscarriage rates. A profoundly deficient luteal phase is believed to be the cause of compromised reproductive outcome. Our personal clinical practice at the AUBMC Fertility Center seems to indicate that a novel GnRH agonist administration protocol is associated with a comparable reproductive performance to standard hCG trigger. In this study, we aim to validate the above clinical impression and assess associated parameters of success. Therefore, a prospective comparative randomized controlled trial will be performed in order to investigate the effect of three repeated doses of GnRH agonist trigger "Triptorelin" accompanied by intensive Luteal Support on the ongoing pregnancy outcome in women who are hyper-responders to ovarian stimulation when undergoing assisted reproductive technology.

Conditions

• Sterility
• Infertility

Interventions

Type	Name	Description
DRUG	Triptorelin	Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-07-01
• Completion: 2021-10-01
• First posted: 2017-05-30
• Last updated: 2023-07-20

Locations

1 site across 1 country: Lebanon