Corifollitropin Alfa Versus Follitropin Beta in High Responders

Eugonia

Status and phase: Unknown; Phase 4

Conditions: Infertility

Treatments: Drug: Puregon; Drug: Elonva

Study type: Interventional

Funder types: Other

Identifiers

NCT02471677

elonva_hyper-responders

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Puregon

Active Comparator group

Description:

Patients will undergo ovarian stimulation using daily injections of recombinant FSH (Puregon), as performed traditionally in IVF cycles

Treatment:

Drug: Puregon

Elonva

Experimental group

Description:

Patients will undergo ovarian stimulation using a single injection of corifollitropin alfa (Elonva)

Treatment:

Drug: Elonva