Corifollitropin Alfa Versus Follitropin Beta in High Responders

• Sponsor: Eugonia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02471677
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Elonva; Drug: Puregon	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Corifollitropin Alfa (Elonva) Versus Follitropin Beta in High Responders: A Randomized Controlled Trial
• Study Start Date: Sep 1, 2015
• Anticipated Primary Completion Date: Sep 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Puregon Patients will undergo ovarian stimulation using daily injections of recombinant FSH (Puregon), as performed traditionally in IVF cycles	Drug: Puregon; follitropin beta (Puregon): daily injections 150 IU from Day 2/3 of menstrual cycle until adequate follicle development is achieved; Other Names: follitropin beta
Experimental: Elonva Patients will undergo ovarian stimulation using a single injection of corifollitropin alfa (Elonva)	Drug: Elonva; corifollitropin alfa (Elonva): a single injection 100 or 150 ug (depending on patient body weight) on Day 2/3 of menstrual cycle; Other Names: corifollitropin alfa

Outcome Measures

Primary Outcome Measures

1. Number of oocytes retrieved [Day of oocyte retrieval (Day 0)]

Secondary Outcome Measures

1. Incidence of severe OHSS [up to 5 days post oocyte retrieval]

2. Follicle development [Day of triggering final oocyte maturation = last day of ovarian stimulation (Day -2 prior to oocyte retrieval)]

3. Fertilization rate [Day 1 after oocyte retrieval]

4. Blastocyst formation rates [Day 5/6 after oocyte retrieval]

5. Number of blastocysts cryopreserved [Day 5/6 after oocyte retrieval]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eugonia Unit of Assisted Reproduction	Athens		Greece	11528

Sponsors and Collaborators

• Eugonia

Investigators

• Study Director: Trifon G Lainas, PhD, Eugonia

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Erratum in: Hum Reprod. 2014 May;29(5):1116-20.
• 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.
• 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. Review.

• Responsible Party: Eugonia
• ClinicalTrials.gov Identifier: NCT02471677
• Other Study ID Numbers: elonva_hyper-responders
• First Posted: Jun 15, 2015
• Last Update Posted: Jun 22, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Eugonia: Ovarian stimulation; corifollitropin alfa; GnRH antagonist protocol; high responders; follitropin beta
• Additional relevant MeSH terms: Infertility; Follicle Stimulating Hormone

Study Results

No Results Posted as of Jun 22, 2015