Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase
NCT ID: NCT03767218
Last Updated: 2023-05-16
Study Results
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Basic Information
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COMPLETED
PHASE3
71 participants
INTERVENTIONAL
2018-11-01
2022-11-25
Brief Summary
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Detailed Description
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Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio
Patients: Oocyte donors (aged 18-36 years)
Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) \> 10 IU/L, till day of trigger.
Oocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Late follicular phase stimulation with recombinant-human FSH
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH \> 10 IU/L, till day of trigger.
Late follicular phase stimulation with recombinant-human FSH
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH \> 10 IU/L, till day of trigger.
Early follicular phase stimulation with recombinant-human FSH
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Early follicular phase stimulation with recombinant-human FSH
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Interventions
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Late follicular phase stimulation with recombinant-human FSH
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH \> 10 IU/L, till day of trigger.
Early follicular phase stimulation with recombinant-human FSH
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Eligibility Criteria
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Inclusion Criteria
* Age from 18 to 36 years
* BMI 19 to 35
* Regular menstrual cycle length i.e. 24-35 days
Exclusion Criteria
* Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/ord AMH \>5ng/ml
* Endometriosis grade 3-4
* Oligo-amenorrhea
* Any untreated endocrine abnormality
18 Years
36 Years
FEMALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Locations
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Universitair Ziekenhuis Brussel
Brussels, , Belgium
Countries
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Other Identifiers
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D2.D12.Bemfola
Identifier Type: -
Identifier Source: org_study_id
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