Clinical trial NCT03169166: The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies
Official title: The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sterility
Infertility
Keywords: GnRH agonist
In Vitro fertilization
Assisted Reproductive Technology
Follicule Maturation
Pregnancy
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 277
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles
timeFrame: 20 weeks from Last Menstrual Period (LMP)
Secondary outcomes:
measure: Oocyte collection rate
timeFrame: On the day of ovum pick-up
Other outcomes:
measure: Fertilization rate
timeFrame: 16-18 hours post insemination
measure: Total pregnancy rate
timeFrame: 10-12 days from embryo transfer
measure: Clinical pregnancy rate
timeFrame: 7 weeks from LMP
measure: Implantation rate
timeFrame: 7 weeks from LMP
measure: Miscarriage rate
timeFrame: From a positive pregnancy test till 20 weeks gestation
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Johnny Awwad, MD
role: PRINCIPAL_INVESTIGATOR
References: