D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists
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.
1 other identifier
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedDecember 3, 2014
December 1, 2014
1.2 years
June 29, 2012
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Consumption of rFSH at the end of the follicular phase
The purpose is to assess the additional need for recFSH in each treatment group
up to 9 months
Secondary Outcomes (1)
Pregnancy rate
Up to 9 months
Study Arms (2)
Day 2 group
PLACEBO COMPARATORPatients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol.
Day 4 group
ACTIVE COMPARATORPatients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa
Interventions
Eligibility Criteria
You may qualify if:
- \< 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
You may not qualify if:
- ≥ 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Brussel
Jette, 1090, Belgium
Related Publications (1)
Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. doi: 10.1093/humrep/deu105. Epub 2014 May 9.
PMID: 24813196DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 4, 2012
Study Start
December 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
December 3, 2014
Record last verified: 2014-12