Clinical trial NCT02471677: Corifollitropin Alfa Versus Follitropin Beta in High Responders
Official title: Corifollitropin Alfa (Elonva) Versus Follitropin Beta in High Responders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Ovarian stimulation
corifollitropin alfa
GnRH antagonist protocol
high responders
follitropin beta
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: Day of oocyte retrieval (Day 0)
Secondary outcomes:
measure: Incidence of severe OHSS
timeFrame: up to 5 days post oocyte retrieval
measure: Follicle development
timeFrame: Day of triggering final oocyte maturation = last day of ovarian stimulation (Day -2 prior to oocyte retrieval)
measure: Fertilization rate
timeFrame: Day 1 after oocyte retrieval
measure: Blastocyst formation rates
timeFrame: Day 5/6 after oocyte retrieval
measure: Number of blastocysts cryopreserved
timeFrame: Day 5/6 after oocyte retrieval
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia Unit of Assisted Reproduction
Study officials:
affiliation: Eugonia
name: Trifon G Lainas, PhD
role: STUDY_DIRECTOR
References:
citation: Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators. A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2009 Dec;24(12):3063-72. doi: 10.1093/humrep/dep291. Epub 2009 Aug 14.
citation: Fauser BC, Alper MM, Ledger W, Schoolcraft WB, Zandvliet A, Mannaerts BM; Engage Investigators. Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF. Reprod Biomed Online. 2010 Nov;21(5):593-601. doi: 10.1016/j.rbmo.2010.06.032. Epub 2010 Jun 30.
citation: Fauser BC, Mannaerts BM, Devroey P, Leader A, Boime I, Baird DT. Advances in recombinant DNA technology: corifollitropin alfa, a hybrid molecule with sustained follicle-stimulating activity and reduced injection frequency. Hum Reprod Update. 2009 May-Jun;15(3):309-21. doi: 10.1093/humupd/dmn065. Epub 2009 Jan 30.