Infertility, Female
Conditions
Keywords
Oocyte donor, Ovarian stimulation
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.
Interventions
COMBINATION_PRODUCTLate 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.
COMBINATION_PRODUCTEarly 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.
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total amount of COC (cumulus-oocyte-complex) | at oocyte aspiration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of gonadotrophins | during the ovarian stimulation | totaal amount of IU (international units) used |
| Number of days needed for ovarian stimulation | during the ovarian stimulation | — |
| Endocrine profile | on menstrual cycle day 2 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 | LH (Luteinising hormone) level |
| Total number of mature oocytes | at day of oocyte aspiration | — |
| Total medication cost | during the ovarian stimulation | — |
| Days of GnRH antagonist use | during the ovarian stimulation | — |
Countries
Belgium
Outcome results
None listed