Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Infertility, Female
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- total amount of COC (cumulus-oocyte-complex)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •oocyte donor patients
- •Age from 18 to 36 years
- •BMI 19 to 35
- •Regular menstrual cycle length i.e. 24-35 days
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
total amount of COC (cumulus-oocyte-complex)
Time Frame: at oocyte aspiration
Secondary Outcomes
- Consumption of gonadotrophins(during the ovarian stimulation)
- 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)
- Total medication cost(during the ovarian stimulation)
- Days of GnRH antagonist use(during the ovarian stimulation)