Corifollitropin Alfa Versus Follitropin Beta in High Responders

Eugonia62 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility

Interventions

ElonvaDRUG

corifollitropin alfa (Elonva): a single injection 100 or 150 ug (depending on patient body weight) on Day 2/3 of menstrual cycle

PuregonDRUG

follitropin beta (Puregon): daily injections 150 IU from Day 2/3 of menstrual cycle until adequate follicle development is achieved

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Eugonia Unit of Assisted Reproduction

Athens, Greece

Outcomes

Primary Outcomes

Number of oocytes retrieved

Time frame: Day of oocyte retrieval (Day 0)

Secondary Outcomes

Incidence of severe OHSS

Time frame: up to 5 days post oocyte retrieval

Follicle development

Time frame: Day of triggering final oocyte maturation = last day of ovarian stimulation (Day -2 prior to oocyte retrieval)

Fertilization rate

Time frame: Day 1 after oocyte retrieval

Blastocyst formation rates

Time frame: Day 5/6 after oocyte retrieval

Number of blastocysts cryopreserved

Time frame: Day 5/6 after oocyte retrieval

Central Contacts

Trifon G Lainas, PhD

CONTACT

00302107236333 ivf@eugonia.com.gr

Data from ClinicalTrials.gov

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