NCT02471677

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

June 8, 2015

Last Update Submit

June 19, 2015

Conditions

Infertility

Keywords

Ovarian stimulationcorifollitropin alfaGnRH antagonist protocolhigh respondersfollitropin beta

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    Day of oocyte retrieval (Day 0)

Secondary Outcomes (5)

  • Incidence of severe OHSS

    up to 5 days post oocyte retrieval

  • 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

  • Blastocyst formation rates

    Day 5/6 after oocyte retrieval

  • Number of blastocysts cryopreserved

    Day 5/6 after oocyte retrieval

Study Arms (2)

Puregon

ACTIVE COMPARATOR

Patients will undergo ovarian stimulation using daily injections of recombinant FSH (Puregon), as performed traditionally in IVF cycles

Drug: Puregon

Elonva

EXPERIMENTAL

Patients will undergo ovarian stimulation using a single injection of corifollitropin alfa (Elonva)

Drug: Elonva

Interventions

ElonvaDRUG

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

Also known as: corifollitropin alfa
Elonva
PuregonDRUG

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

Also known as: follitropin beta
Puregon

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-40 years
  • Polycystic ovaries (PCO) or polycystic ovary syndrome (PCOS)
  • no endometriotic cyst

You may not qualify if:

  • Patients with poor response
  • Patients using human chorionic gonadotropin (hCG) for triggering final oocyte maturation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia Unit of Assisted Reproduction

Athens, 11528, Greece

Location

Related Publications (3)

  • 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.

    PMID: 19684043BACKGROUND

  • 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.

    PMID: 20843746BACKGROUND

  • 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.

    PMID: 19182099BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptidefollitropin beta

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Trifon G Lainas, PhD

    Eugonia

    STUDY DIRECTOR

Central Study Contacts

Trifon G Lainas, PhD

CONTACT

00302107236333ivf@eugonia.com.gr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 15, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations

GR(1)