Back to resultsD2 Versus D4 Corifollitropin Alfa in GnRH Antagonists
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
corifollitropin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring ICSI, GnRH antagonist, corifollitropin alfa
Eligibility 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)
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Day 2 group
Day 4 group
Arm Description
Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol.
Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa
Outcomes
Primary Outcome Measures
Consumption of rFSH at the end of the follicular phase
The purpose is to assess the additional need for recFSH in each treatment group
Secondary Outcome Measures
Pregnancy rate
The purpose is to study the pregnancy rate in each treatment group
Full Information
NCT ID
NCT01633580
First Posted
June 29, 2012
Last Updated
December 2, 2014
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT01633580
Brief Title
D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ICSI, GnRH antagonist, corifollitropin alfa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Day 2 group
Arm Type
Placebo Comparator
Arm Description
Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol.
Arm Title
Day 4 group
Arm Type
Active Comparator
Arm Description
Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa
Intervention Type
Drug
Intervention Name(s)
corifollitropin alfa
Intervention Description
long acting FSH
Primary Outcome Measure Information:
Title
Consumption of rFSH at the end of the follicular phase
Description
The purpose is to assess the additional need for recFSH in each treatment group
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
The purpose is to study the pregnancy rate in each treatment group
Time Frame
Up to 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
24813196
Citation
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.
Results Reference
derived
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D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists
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