NCT02490150CompletedPhase 4
Administration of Corifollitropin Alfa on Day 5 Versus Day 7 After Last Oral Contraceptive Pill in a GnRH (Gonadotropin-releasing Hormone ) Antagonist Protocol in Donors
Institut Universitari Dexeus1 site in 1 country70 target enrollmentStarted: February 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- total dosis of rFSH (IU)
Study Overview
Brief Summary
To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women 18-35 y old ,with regular spontaneous menstrual cycles of 25-30 days length
- •Who had vaginal sexual intercourse or have no inconvenient for vaginal explorations
- •Donors can´t have more than 6 children (neither own or after donations)
- •Not be adopted or being born after a gamete donation pregnancy
- •BMI between 18-28 kg/m2
- •Height > 1.55cm
- •Gynecological and general examination with Pap smear, HIV, HCV (hepatitis C virus ), HBV (hepatitis B virus ) and RPR(rapid plasma reagin test ) negative serology, and with normal karyotype
- •No abnormal Psychological profile
- •Discard any disease: blood disorders, neurodegenerative/psychiatric diseases, Fragile X Syndrome, cystic fibrosis carrier, oncology diseases.
- •Without psychological/psychiatric family history
- •Will conform to the protocol for the duration of the study
- •Willingness of adhesion to protocol during the whole study period
- •Signed informed consent
Exclusion Criteria
- •Polycystic ovarian syndrome
- •Antral follicle count > 20
- •Hypersensitivity to the active substance or any of the excipients
- •Abnormal vaginal bleeding of unknown ethiology
- •Presence of ovarian cysts or increased size ovaries
- •History of ovarian hyperstimulation syndrome
- •Previous controlled ovarian stimulation cycle with more than 30 follicles ≥ 11mm
- •Previous abdominal surgery that contraindicated the practice of follicular puncture
- •HIV, HCV, HBV positive serology in women or partner
- •Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...)
Arms & Interventions
Day 5
Experimental
Administration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors.
Intervention: Corifollitropin alfa (Drug)
Day 7
Active Comparator
Administration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors.
Intervention: Corifollitropin alfa (Drug)
Outcomes
Primary Outcomes
total dosis of rFSH (IU)
Time Frame: donors will be followed until the end of stimulation period, an expected average of 15 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Ignacio Rodriguez
MD.
Institut Universitari Dexeus
Study Sites (1)
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