Infertility Clinical Trial
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.
Verified date | December 2014 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: FAGG |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel | Jette |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Pregnancy rate | The purpose is to study the pregnancy rate in each treatment group | Up to 9 months | No |
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