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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169166
• Other study ID #: AmericanUBMCGNRH
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2023
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Normal uterine cavity (as assessed by hysteroscopy or HSG).

• Normal hormonal investigation: TSH, PRL.

• More than 15 follicles (=12 mm in diameter) on ultrasound, and/or estradiol level of > 3500 pg/ml on the day of trigger.

Exclusion Criteria:

• History of three or more miscarriages.

• History of three or more previous IVF failures.

• Abnormal uterine cavity (Hysteroscopy or HSG).

Related Conditions & MeSH terms

• Infertility
• Sterility

Intervention

Drug:
• Triptorelin
Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fertilization rate		16-18 hours post insemination
Other	Total pregnancy rate		10-12 days from embryo transfer
Other	Clinical pregnancy rate		7 weeks from LMP
Other	Implantation rate		7 weeks from LMP
Other	Miscarriage rate		From a positive pregnancy test till 20 weeks gestation
Primary	Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles		20 weeks from Last Menstrual Period (LMP)
Secondary	Oocyte collection rate	oocyte maturation rate ovarian volume on the day of hCG titer	On the day of ovum pick-up