D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

This study is currently recruiting participants.
Verified July 2012 by Universitair Ziekenhuis Brussel
Sponsor:
Information provided by (Responsible Party):
Blockeel Christophe, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01633580
First received: June 29, 2012
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Consumption of rFSH at the end of the follicular phase [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The purpose is to study the pregnancy rate in each treatment group


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633580

Contacts
Contact: Christophe Blockeel, MD, PhD +3224776699 cblockee@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Jette, Belgium, 1090
Contact: Christophe Blockeel, MD, PhD    +3224776699    cblockee@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

No publications provided

Responsible Party: Blockeel Christophe, MD, PhD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01633580     History of Changes
Other Study ID Numbers: 2012/019
Study First Received: June 29, 2012
Last Updated: July 4, 2012
Health Authority: Belgium: FAGG

Keywords provided by Universitair Ziekenhuis Brussel:
ICSI
GnRH antagonist
corifollitropin alfa

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 23, 2014