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Corifollitropin Alfa Versus Follitropin Beta in High Responders

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ClinicalTrials.gov Identifier: NCT02471677
Recruitment Status : Unknown
Verified June 2015 by Eugonia.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2015
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

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 Name: 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 Name: corifollitropin alfa




Primary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: Day of oocyte retrieval (Day 0) ]

Secondary Outcome Measures :
  1. Incidence of severe OHSS [ Time Frame: up to 5 days post oocyte retrieval ]
  2. Follicle development [ Time Frame: Day of triggering final oocyte maturation = last day of ovarian stimulation (Day -2 prior to oocyte retrieval) ]
  3. Fertilization rate [ Time Frame: Day 1 after oocyte retrieval ]
  4. Blastocyst formation rates [ Time Frame: Day 5/6 after oocyte retrieval ]
  5. Number of blastocysts cryopreserved [ Time Frame: Day 5/6 after oocyte retrieval ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471677


Contacts
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Contact: Trifon G Lainas, PhD 00302107236333 ivf@eugonia.com.gr

Locations
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Greece
Eugonia Unit of Assisted Reproduction
Athens, Greece, 11528
Contact: Trifon G Lainas, PhD    00302107236333    ivf@eugonia.com.gr   
Principal Investigator: Trifon G Lainas, PhD         
Sponsors and Collaborators
Eugonia
Investigators
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Study Director: Trifon G Lainas, PhD Eugonia

Publications:
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Responsible Party: Eugonia
ClinicalTrials.gov Identifier: NCT02471677    
Other Study ID Numbers: elonva_hyper-responders
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015
Keywords provided by Eugonia:
Ovarian stimulation
corifollitropin alfa
GnRH antagonist protocol
high responders
follitropin beta
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs