A Phase 4 interventional study of Triptorelin in Sterility and Infertility, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by American University of Beirut Medical Center · Phase 4, Interventional, and Treatment
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.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 277 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart (0.3/0.2/0.2mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.
Drug: Triptorelin
Triptorelin pre-filled syringes will be administered subcutaneously in a single dose (0.3 mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.
Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart
Also known as: Gonapeptyl
Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles
Time frame: 20 weeks from Last Menstrual Period (LMP)
Oocyte collection rate
oocyte maturation rate ovarian volume on the day of hCG titer
Time frame: On the day of ovum pick-up
Fertilization rate
Time frame: 16-18 hours post insemination
Total pregnancy rate
Time frame: 10-12 days from embryo transfer
Clinical pregnancy rate
Time frame: 7 weeks from LMP
Implantation rate
Time frame: 7 weeks from LMP
Miscarriage rate
Time frame: From a positive pregnancy test till 20 weeks gestation
Plan to share: Undecided
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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American University of Beirut Medical Center