Infertility, Sterility
Conditions
Keywords
GnRH agonist, In Vitro fertilization, Assisted Reproductive Technology, Follicule Maturation, Pregnancy
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.
Interventions
DRUGTriptorelin
Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles | 20 weeks from Last Menstrual Period (LMP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte collection rate | On the day of ovum pick-up | oocyte maturation rate ovarian volume on the day of hCG titer |
Other
| Measure | Time frame |
|---|---|
| Total pregnancy rate | 10-12 days from embryo transfer |
| Implantation rate | 7 weeks from LMP |
| Miscarriage rate | From a positive pregnancy test till 20 weeks gestation |
| Clinical pregnancy rate | 7 weeks from LMP |
| Fertilization rate | 16-18 hours post insemination |
Countries
Lebanon
Outcome results
None listed