Corifollitropin Alfa Versus Follitropin Beta in High Responders

Phase 4

• Conditions: Infertility
• Interventions: Drug: Elonva; Drug: Puregon

• Registration Number: NCT02471677
• Lead Sponsor: Eugonia

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.

Study Timeline

• Status Verified: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-06-22
• Study Start: 2015-09
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elonva	Elonva	Patients will undergo ovarian stimulation using a single injection of corifollitropin alfa (Elonva)
Puregon	Puregon	Patients will undergo ovarian stimulation using daily injections of recombinant FSH (Puregon), as performed traditionally in IVF cycles

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	Day of oocyte retrieval (Day 0)

Secondary Outcome Measures

Name	Time	Method
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
Incidence of severe OHSS	up to 5 days post oocyte retrieval
Blastocyst formation rates	Day 5/6 after oocyte retrieval
Number of blastocysts cryopreserved	Day 5/6 after oocyte retrieval

Trial Locations

Locations (1)

Eugonia Unit of Assisted Reproduction; 🇬🇷 Athens, Greece