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D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

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ClinicalTrials.gov Identifier: NCT01633580
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Blockeel Christophe, Universitair Ziekenhuis Brussel

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Drug: corifollitropin alfa Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
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.
Study Start Date : December 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Pregnancy rate [ Time Frame: Up to 9 months ]
    The purpose is to study the pregnancy rate in each treatment group



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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633580


Locations
Belgium
UZ Brussel
Jette, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel

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
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

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

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