Corifollitropin Alfa Versus Follitropin Beta in High Responders

June 19, 2015 updated by: Eugonia

Corifollitropin Alfa (Elonva) Versus Follitropin Beta in High Responders: A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Eugonia Unit of Assisted Reproduction
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of oocytes retrieved
Time Frame: Day of oocyte retrieval (Day 0)
Day of oocyte retrieval (Day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of severe OHSS
Time Frame: up to 5 days post oocyte retrieval
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)
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
Day 1 after oocyte retrieval
Blastocyst formation rates
Time Frame: Day 5/6 after oocyte retrieval
Day 5/6 after oocyte retrieval
Number of blastocysts cryopreserved
Time Frame: Day 5/6 after oocyte retrieval
Day 5/6 after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eugonia

Investigators

  • Study Director: Trifon G Lainas, PhD, Eugonia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Estimate)

June 22, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • elonva_hyper-responders

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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