D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Universitair Ziekenhuis Brussel.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Universitair Ziekenhuis Brussel

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014