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D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

This study has been completed.
Information provided by (Responsible Party):
Blockeel Christophe, Universitair Ziekenhuis Brussel Identifier:
First received: June 29, 2012
Last updated: December 2, 2014
Last verified: December 2014
The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.

Condition Intervention Phase
Infertility Drug: corifollitropin alfa Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Follicular Phase Endocrine Characteristics During Ovarian Stimulation and GnRH Antagonist Co-treatment for IVF; Randomized Trial Comparing Corifollitropin Alfa (Elonva) Initiated on Cycle Day 2 or 4.

Further study details as provided by Blockeel Christophe, Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Consumption of rFSH at the end of the follicular phase [ Time Frame: up to 9 months ]
    The purpose is to assess the additional need for recFSH in each treatment group

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: Up to 9 months ]
    The purpose is to study the pregnancy rate in each treatment group

Enrollment: 67
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Day 2 group
Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol.
Drug: corifollitropin alfa
long acting FSH
Active Comparator: Day 4 group
Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa
Drug: corifollitropin alfa
long acting FSH

Detailed Description:
Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.

Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • < 36 years old on day of randomisation
  • FSH < 12 (in the early follicular phase)
  • Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
  • Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
  • BMI ≤ 29
  • Weight > 60 kg
  • < 3 previous trials
  • ICSI
  • Randomisation at out-patient clinic

Exclusion Criteria:

  • ≥ 36 years old on day of randomisation
  • Endometriosis ≥ grade 3
  • PCOS
  • Poor responders (development of < 4 follicles in a previous IVF/ICSI cycle)
  • Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01633580

UZ Brussel
Jette, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Blockeel Christophe, MD, PhD, Universitair Ziekenhuis Brussel Identifier: NCT01633580     History of Changes
Other Study ID Numbers: 2012/019
Study First Received: June 29, 2012
Last Updated: December 2, 2014

Keywords provided by Blockeel Christophe, Universitair Ziekenhuis Brussel:
GnRH antagonist
corifollitropin alfa

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on September 18, 2017