Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase
- Conditions
- Infertility, Female
- Interventions
- Combination Product: Early follicular phase stimulation with recombinant-human FSHCombination Product: Late follicular phase stimulation with recombinant-human FSH
- Registration Number
- NCT03767218
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.
- Detailed Description
Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 71
- oocyte donor patients
- Age from 18 to 36 years
- BMI 19 to 35
- Regular menstrual cycle length i.e. 24-35 days
- Patients with AMH <1.1 ng/ml and/or AFC<7
- Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/ord AMH >5ng/ml
- Endometriosis grade 3-4
- Oligo-amenorrhea
- Any untreated endocrine abnormality
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early follicular phase stimulation with recombinant-human FSH 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. Late follicular phase stimulation with recombinant-human FSH 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.
- Primary Outcome Measures
Name Time Method total amount of COC (cumulus-oocyte-complex) at oocyte aspiration
- Secondary Outcome Measures
Name Time Method Consumption of gonadotrophins during the ovarian stimulation totaal amount of IU (international units) used
Total number of mature oocytes at day of oocyte aspiration Number of days needed for ovarian stimulation during the ovarian stimulation Endocrine profile on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group Estradiol level
Total medication cost during the ovarian stimulation Days of GnRH antagonist use during the ovarian stimulation
Trial Locations
- Locations (1)
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium