Infertility
Conditions
Keywords
Ovarian stimulation, corifollitropin alfa, GnRH antagonist protocol, high responders, follitropin beta
Brief summary
The purpose of this randomized controlled trial (RCT) is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for in vitro fertilization treatment using a gonadotropin-releasing hormone (GnRH) antagonist protocol combined with GnRH agonist trigger and cryopreservation of all embryos.
Detailed description
Corifollitropin alfa, a novel fusion protein lacking luteinizing hormone (LH) activity, has a longer elimination half-life and extended time to peak levels than recombinant follicle stimulating hormone (rFSH). A single injection of corifollitropin alfa may replace seven daily injections follitropin beta during the first week of ovarian stimulation, reducing patient discomfort. The purpose of this RCT is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, as well as hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for IVF using a GnRH antagonist protocol. In addition, incidence of unexpected ovarian hyperstimulation syndrome (OHSS) will be evaluated, although it is anticipated that GnRH agonist triggering will eliminate occurrence of the syndrome.
Interventions
Sponsors
Eugonia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18-40 years * Polycystic ovaries (PCO) or polycystic ovary syndrome (PCOS) * no endometriotic cyst
Exclusion criteria
* Patients with poor response * Patients using human chorionic gonadotropin (hCG) for triggering final oocyte maturation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved | Day of oocyte retrieval (Day 0) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of severe OHSS | up to 5 days post oocyte retrieval |
| Follicle development | Day of triggering final oocyte maturation = last day of ovarian stimulation (Day -2 prior to oocyte retrieval) |
| Fertilization rate | Day 1 after oocyte retrieval |
| Blastocyst formation rates | Day 5/6 after oocyte retrieval |
| Number of blastocysts cryopreserved | Day 5/6 after oocyte retrieval |
Countries
Greece
Contacts
Primary ContactTrifon G Lainas, PhD
Outcome results
None listed